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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 K863186
Device Name BIOCHEM CO/OX 1000
Applicant
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Applicant Contact KEITH R HARPER
Correspondent
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Correspondent Contact KEITH R HARPER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/19/1986
Decision Date 11/07/1986
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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