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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 K802614
Device Name ENGSTROM EMMA ANESTHETIC GAS MONITOR
Applicant
LKB INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LKB INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1620
Classification Product Code
CBS  
Date Received10/21/1980
Decision Date 01/07/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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