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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 K892854
Device Name ANESTHETIC AGENT MONITOR
Applicant
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Applicant Contact DER RUHR
Correspondent
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Correspondent Contact DER RUHR
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received04/18/1989
Decision Date 10/13/1989
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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