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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K803260
Device Name SENSOMAT MUSCLE/TISSUE PH
Applicant
BIOCHEM INTERNATIONAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOCHEM INTERNATIONAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received12/24/1980
Decision Date 02/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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