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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 K042631
Device Name EAR THERMOMETER, MODEL WL-320X
Applicant
Innovatech, Inc.
No 5, Aly. 5,
Ln. Cheng Hsing, Chung Ching
Pei Tun Dist. Taichung,  TW
Applicant Contact TONY C CHANG
Correspondent
Innovatech, Inc.
No 5, Aly. 5,
Ln. Cheng Hsing, Chung Ching
Pei Tun Dist. Taichung,  TW
Correspondent Contact TONY C CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/27/2004
Decision Date 12/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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