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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 K890446
Device Name ANESTHETIC GAS MONITOR
Applicant
Bruel & Kjaer Instruments, Inc.
185 Forest St.
Marlborough,  MA 
Applicant Contact AAGE RUBY
Correspondent
Bruel & Kjaer Instruments, Inc.
185 Forest St.
Marlborough,  MA 
Correspondent Contact AAGE RUBY
Regulation Number868.1620
Classification Product Code
CBS  
Date Received01/27/1989
Decision Date 08/11/1989
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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