OMRON MODEL 514N TYMPANIC THERMOMETER

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 1 2005 Mr. Iwao Kojima Director of Technology Omron Healthcare, Incorporated 1200 Lakeside Drive Bannockburn, Illinois 60015-1243 Re: K051233 K051255 Trade/Device Name: OMRON Tympanic Thermometer, Model MC-514N Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 10, 2005 Received: May 27, 2005 Dear Mr. Kojima: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection broker by the device is substantially equivalent (for the relevenced above and have determined and to legally marketed predicate devices marketed in indications for use stated in the cherosals, to esgared, to enactment date of the Medical Device interstate commerce prior to May 20, 1970, and existed in accordance with the provisions of Afficiluments, on to devroes that nations of the that do not require approval of a premarket the Federal FUOd, Drug, and Cosmetion its (Pres) ----------------------------------------------------------------------------------------------------------------------------approval application (1 MIT). confors provisions of the Fist. "The gistration, 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 II your device is classified (see as veriles controls. Existing major regulations affecting (PMA), it may of subject to such adata. Frances and Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Kojima Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that TDA s issualled on that your device complies with other requirements mean that IDA nas made a deceminations administered by other Federal agencies. of the Act of ally i cutures and regarments, including, but not limited to: registration You must comply with an the Fict 5 requirement 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rat 800); god i and listing (21 CFR Part 607), laooling (21 CFR Pat 820); and if 820); and if requirements as set forth in the quality brovisions (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 5 10(k) I his letter will anow you to begill mailering your device of your device to a premarket noutication. Thic PDF Imazing or 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), a If you desire specific advice to: Jour de at (240) 276-0115. Also, please note the regulation prease contact uic Office or Comphanes are (210) - 11 - 1 CFR Part 807.97). You entitled, "Misbranding by reference to premarket notification" (21 CFR Part from the may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on Jones Assistance at its toll-free Division of Birland or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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 {2}------------------------------------------------ ## Indications for Use Statement K 051233 510(k) Number OMRON Device Name Tympanic Thermometer, Model MC-514N Intermittent temperature measurement of the neonatal, pediatric Indication for Use and adult population through the patient's auditory canal using a battery operated infrared sensor. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ X (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Qut (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division of Anesthesiology, General Devices Division of Ancolnoothoontal Device 510(k) Number 2 002