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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 K920061
Device Name HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact FREDERICK A GUSTAFS
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact FREDERICK A GUSTAFS
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received01/07/1992
Decision Date 03/30/1992
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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