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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K842303
Device Name MICROSPAN -PH MONITOR
Applicant
Biochem International, Inc.
P.O. Box 13157
Milwaukee,  WI  53213
Applicant Contact DER RUHR
Correspondent
Biochem International, Inc.
P.O. Box 13157
Milwaukee,  WI  53213
Correspondent Contact DER RUHR
Regulation Number868.5470
Classification Product Code
CBF  
Date Received06/11/1984
Decision Date 10/12/1984
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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