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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K931394
Device Name CM5000R REMOTE INDICATOR
Applicant
Canadian Monaghan , Ltd.
220 Adelaide St. S.
London, Ontario,  CA N5Z 3L1
Applicant Contact CAROL MASON
Correspondent
Canadian Monaghan , Ltd.
220 Adelaide St. S.
London, Ontario,  CA N5Z 3L1
Correspondent Contact CAROL MASON
Regulation Number868.2600
Classification Product Code
CAP  
Date Received03/19/1993
Decision Date 07/01/1993
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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