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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 K942737
Device Name POET IQ WITH FIVE AGENT CAPABILITY
Applicant
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Applicant Contact ALEX KAPLAN
Correspondent
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Correspondent Contact ALEX KAPLAN
Regulation Number868.1620
Classification Product Code
CBS  
Date Received06/10/1994
Decision Date 02/09/1995
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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