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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 K010224
Device Name NPAC MULTI-USE THERMOMETER, MODEL TD400
Applicant
NORM PACIFIC AUTOMATION CORP.
3F, NO. 31, HU-PIN ROAD #1
SBIP
HSIN-CHU,  TW
Applicant Contact CHI-CHU WU CHEN
Correspondent
NORM PACIFIC AUTOMATION CORP.
3F, NO. 31, HU-PIN ROAD #1
SBIP
HSIN-CHU,  TW
Correspondent Contact CHI-CHU WU CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/24/2001
Decision Date 03/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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