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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K082266
Device Name DIGITAL CLINICAL THERMOMETER MODEL V9XX
Applicant
AMPEROR-ELECTRONIC(SZ) CO., LTD
KU-SU VILLAGE, SHI-SHAN TOWN
BAOAN COUNTY
SHENZHEN, GUANDONG,  CN 518126
Applicant Contact LARRY YANG
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/11/2008
Decision Date 11/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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