FAST THERMOMETER MODELS ST713C AND ST713F

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 3 2001 Mesure Technology C/O Mr. Phil Zulueta Z7 International P.O. Box 2249 Mission Viejo, California 92690 K011585 Re : Clinical Electronic Thermometer Trade/Device Name: 880.2910 Requlation Number: Regulatory Class: II Product Code: FLL Dated: May 19, 2001 Received: May 23, 2001 Dear Mr. Zulueta: 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {1}------------------------------------------------ Page 2 — Mr. Zulueta this response to your premarket notification submission does this response to your promobility have under sections 531 not allect any obligation you might under the Electronic Chrough 542 OF the not 10 provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as Inis lecter will arrow your market notification. The FDA described in your srown provilence of your device to a legally Illuling of substancial equice in a classification for your marketed predicate device robates to proceed to the market. If you desire specific advice for your device on our labeling If you desire bpcorner and additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (50), dvertising of your device, please contact the promocron and adversibling on Journal (1301) Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from the Bivibion or billion (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 1 Statement of Indications for Use Page 1 of 1. 510(k) Number (if known) 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Clinical Electronic Thermometer Device Name: ____________________________ Indications for Use: ィ The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Pauline Cucente (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) Z7 International "Serving the Electronics Industry" 510(k) ST713 - Page 1-5