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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, enflurane, gaseous-phase (anesthetic concentration)
510(k) Number K994188
Device Name MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
Applicant
AGILENT TECHNOLOGIES, GMBH
HERRENBERGER STRASSE 130
BOEBLINGEN,  DE 71034
Applicant Contact HERBERT VAN DYK
Correspondent
AGILENT TECHNOLOGIES, GMBH
HERRENBERGER STRASSE 130
BOEBLINGEN,  DE 71034
Correspondent Contact HERBERT VAN DYK
Regulation Number868.1500
Classification Product Code
CBQ  
Subsequent Product Code
CBS  
Date Received12/13/1999
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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