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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 K101736
Device Name NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
Applicant
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD.
19TH BUILDING, 5TH REGION
BAIWANGXIN IND. PK. SONGBAI RD
BAIMANG XILI NANSHAN SHENZHEN,  CN
Applicant Contact DENG AIGUO
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/21/2010
Decision Date 07/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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