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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K910381
Device Name BIOCHEM TEMPERATURE/ FIO2 MODULE
Applicant
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Applicant Contact DAVID A UHEN
Correspondent
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Correspondent Contact DAVID A UHEN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received01/29/1991
Decision Date 08/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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