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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 K890010
Device Name CM 7000MR
Applicant
Trudell Medical
926 Leathorne St., London
Ontario,  CA N5Z 3M5
Applicant Contact MARTIN FOLEY
Correspondent
Trudell Medical
926 Leathorne St., London
Ontario,  CA N5Z 3M5
Correspondent Contact MARTIN FOLEY
Regulation Number868.2600
Classification Product Code
CAP  
Date Received01/03/1989
Decision Date 06/12/1989
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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