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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 K914295
Device Name ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
Applicant
Bruel & Kjaer
18 Naerum Hovedgode
Naerum 2850,  DK
Applicant Contact AAGE RUBY
Correspondent
Bruel & Kjaer
18 Naerum Hovedgode
Naerum 2850,  DK
Correspondent Contact AAGE RUBY
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received09/09/1991
Decision Date 04/10/1992
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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