TEMPTOUCH DERMAL THERMOMETER

{0}------------------------------------------------ Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the shape of a bird's head and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 8 2005 Xilas Medical, Incorporated C/O Ms. Silvia Ankova Responsible Third Party Official Responsions Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096 Re: K050137 Trade/Device Name: TempTouch® Prade Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 1, 2005 Received: March 2, 2005 Dear Ms. Ankova: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Scellon 310(t) promazine is substantially equivalent (for the referenced above and have decimined the arrest as and interest predicate devices marketed in indications for use stated in the enclosure) to legally marketed of the Medical indications for use stated in the chelosator to regalized of the Medical Device interstate commerce prior to way 20, 1770, ce ssified in accordance with the provisions of Amendments, or to devices that have been receive enroyel of a premarket Amendments, of to devices mat nave been rocksoned and require approval of a premarket. The Federal Food, Drug, and Cosmetic Act (Act) that do not requires to the geperal the Federal Food, Drug, and Cosmetic Act (recy therefore, subject to the general approval application (PMA). You may, therefore, market the device, subject to the general approval application (11MT). Four rely controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requiremond for aibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (See above) in the existing major regulations affecting (PMA), It may of subject to such adamer coal Regulations, Title 21, Parts 800 to 898. In the Archively your device can be found in the Gode of Preceives addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Ms. Ankova 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. or me 1 co or any 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 vour 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 (240) 276-0115. 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/industry/support/index.html. Sincerelv vours. Gustave M. Michel O.D. 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 {2}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE 510(k) Number if known: ______________________________________________________________________________________________________________________________________________________ Device Name: TempTouch®_______________________________________________________________________________________________________________________________________________________ Indications for use: "The TempTouch® Dermal Thermometer is an infrared thermometer "The "The "Ciffication" Delina" "Desurement of skin surface temperature of people of all ages." Prescription use:___ XX Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter use: (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Signature . Ession Sign-Off) . . Mon Ogn sthesiology, General Hospital, in Section Control Dental Devices Number K456132