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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 K871083
Device Name CM 5000 MONITOR AIRWAY PRESSURE
Applicant
Canadian Monaghan , Ltd.
920 Leathorne St. , London
Ontario N5z 3m5,  CA
Applicant Contact MARTIN FOLEY
Correspondent
Canadian Monaghan , Ltd.
920 Leathorne St. , London
Ontario N5z 3m5,  CA
Correspondent Contact MARTIN FOLEY
Regulation Number868.2600
Classification Product Code
CAP  
Date Received03/18/1987
Decision Date 04/08/1987
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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