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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 K923433
Device Name AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
Applicant
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Applicant Contact SEPPO LUODE
Correspondent
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Correspondent Contact SEPPO LUODE
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received07/13/1992
Decision Date 07/22/1993
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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