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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 K031907
Device Name NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551
Applicant
Norm Pacific Automation Corp.
3f, # 31, Hu-Pin Rd. #1
Sbip
Hsin-Chu,  TW
Applicant Contact CHI-CHU WU CHEN
Correspondent
Norm Pacific Automation Corp.
3f, # 31, Hu-Pin Rd. #1
Sbip
Hsin-Chu,  TW
Correspondent Contact CHI-CHU WU CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/20/2003
Decision Date 08/21/2003
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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