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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, Halothane, Gaseous-Phase (Anesthetic Conc.)
510(k) Number K960490
Device Name AS/3 COMPACT AIRWAY MODULE M-CAIOV
Applicant
Datex Medical Instrumentation, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact VINCENT RAUSCHER
Correspondent
Datex Medical Instrumentation, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact VINCENT RAUSCHER
Regulation Number868.1620
Classification Product Code
CBS  
Date Received02/02/1996
Decision Date 05/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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