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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 -3500
Applicant Contact FREDERICK A GUSTAFS
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
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
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