9 SECOND DIGITAL THERMOMETER, MODEL BT-S09

{0}------------------------------------------------ K033082 DEC - 3 2003 Image /page/0/Picture/2 description: The image shows the logo for Media Trade Corporation, with the acronym "MTC" in large, bold, black font on the left side. To the right of "MTC" is the full name "Media Trade Corporation" in a smaller, serif font. A horizontal black line runs beneath the text, emphasizing the company's name. The overall design is clean and professional, suggesting a well-established business. 11820 Red Hibiscus Drive Bonita Springs, FL 34135 Tel (941) 948-2001 – Fax (941) 948-2002 E-mail: GG(a)mediatradecorp.com Web: www.mediatradecorp.com ## 510(k) Summary | Submitter's Name: | Guenter Ginsberg<br>Media Trade Corporation | |--------------------|--------------------------------------------------------------------------------------------------------------------------------| | Address: | 11820 Red Hibiscus Drive<br>Bonita Springs, FL 34135 | | Phone: | (941) 948-2001 | | Fax: | (941) 948-2002 | | E-mail: | gg@mediatradecorp.com | | Contact: | Guenter Ginsberg | | Date of Summary: | September 24, 2003 | | Trade Name: | 9 second Digital Thermometer<br>Model BT-S09 | | Classification: | Thermometer, Clinical, Electronic<br>Product Code: FLL<br>Regulation No. 880.2910<br>Class: II<br>Panel: 80 (General Hospital) | | Predicate Devices: | Microlife MT3001 (QTIJA)<br>K 031958 | {1}------------------------------------------------ Page -2- (510k Summary) The 9 second Digital Thermometer is designed to Device Description: measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed. The 9 second Digital Thermometer is intended for Intended Use: the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. The 9 second Digital Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device from Microlife. The main difference is the physical size, shape and weight. The 9 second Digital Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and > effectiveness. This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device "Microlife MT3001 (QT1JA1). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 3 2003 Metatech Corporation Limited C/O Mr. Guenter A. Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135 Re: K033082 Trade/Device Name: Metatech Corporation Limited 9 Second Digital Thermometer, Model BT-S09 Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: FLL Product Code: II Dated: September 25, 2003 Received: September 29, 2003 Dear Mr. Ginsderg: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a promarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting ( vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ## Page 2 - Mr. Ginsberg Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runion Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 510(k) NUMBER (IF KNOWN): KC3308 DEVICE NAME : METATECH Co. Ltd., 9-second Digital Thermometer INDICATIONS FOR USE: This device is an electronic clinical thermometer using a themistor probe sensor to detect This device is an electronic cinical mentions oral, rectal or axillary temperatures. It is intended for home use on people of all ages. Palace Ceccenite Division Sian-Off ivision of Anesthesiology, General Hospital ction Control, Dental D 510(k) Number. K033082 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use V (Optional Format 1-2-