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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K920082
Device Name BIOCHEM MODEL 3301 NEWOX1 OXIMETER
Applicant
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Applicant Contact DAVID UHEN
Correspondent
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Correspondent Contact DAVID UHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/07/1992
Decision Date 01/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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