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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 K070578
Device Name CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
Applicant
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
6F,NO.88 NING JING ST.,
KEELUNG,,  TW
Applicant Contact CHENG ROEI-SHENG
Correspondent
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
6F,NO.88 NING JING ST.,
KEELUNG,,  TW
Correspondent Contact CHENG ROEI-SHENG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/01/2007
Decision Date 07/11/2007
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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