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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. SOUTH
LONDON, ONTARIO,  CA N5Z 3L1
Applicant Contact CAROL MASON
Correspondent
CANADIAN MONAGHAN LTD.
220 ADELAIDE ST. SOUTH
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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