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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 K943458
Device Name AS/3 AIRWAY MODULE
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
27 TEOLLISUUSKATU
HELSINKI,  FI
Applicant Contact VINCENT RAUSCHER
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
27 TEOLLISUUSKATU
HELSINKI,  FI
Correspondent Contact VINCENT RAUSCHER
Regulation Number868.1620
Classification Product Code
CBS  
Date Received07/18/1994
Decision Date 02/14/1995
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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