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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 K873953
Device Name CM 5000R REMOTE AIRWAY PRESSURE
Applicant
CANADIAN MONAGHAN LTD.
920 LEATHORNE STREET , LONDON
ONTARIO N5Z 3M5,  CA
Applicant Contact MARTIN FOLEY
Correspondent
CANADIAN MONAGHAN LTD.
920 LEATHORNE STREET , LONDON
ONTARIO N5Z 3M5,  CA
Correspondent Contact MARTIN FOLEY
Regulation Number868.2600
Classification Product Code
CAP  
Date Received09/28/1987
Decision Date 10/27/1987
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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