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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K160802
Device Name Infrared Forehead Thermometer, FT-100A
Applicant
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
38 YANGJIATANG, SANDUN, WESTLAKE DISTRICT
HANGZHOU CITY,  CN 310030
Applicant Contact JIAQIANG WAN
Correspondent
IRC
7808 RUSH CREEK DRIVE
PASCO,  WA  99301
Correspondent Contact CHARLIE MACK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/23/2016
Decision Date 08/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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