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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 K023500
Device Name DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
Applicant
Innovatech, Inc.
No 5, Aly. 5,
Ln. Cheng Hsing, Chung Ching
Pei Tun Dist. Taichung,  TW
Applicant Contact TONY C.S. CHANG
Correspondent
Innovatech, Inc.
No 5, Aly. 5,
Ln. Cheng Hsing, Chung Ching
Pei Tun Dist. Taichung,  TW
Correspondent Contact TONY C.S. CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/18/2002
Decision Date 12/13/2002
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
Predetermined Change
Control Plan Authorized		 No
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