QUICK CHECK INSTANT THERMOMETER

{0}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 7 1998 MAY Mr. Jim Hastie ·VP, Marketing EJB Medical, Incorporated 250 El Camino Real, Suite 214 Tustin, California 92780 Re : K971831 Quick Check Instant Thermometer Trade Name: Requlatory Class: II Product Code: FLL April 8, 1998 Dated: Received: April 10, 1998 Dear Mr. Hastie: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with --------------------------------------------------------------------------------------------------------------the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Hastie the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaffgov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ P.2/2 S10(k) Number (if known): K971831 Device Name: QUICK CHECK INSTANT THERMOMETER ## Indications For Use: THIS DEVICE IS INTENDED TO BE USED PHIN IT IS DESIRED TO MEASURE & PERSON'S BODY TEMPERATURE. - . . (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Patricio Cucenic (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K971831 Presention Use (Per 21 CFR 801,109) OR · Over-The-Counter Use __ I (Optional Formal 1-2-96)