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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K853047
Device Name MONAGHAN RVM, MODEL 760 OR MODEL 761
Applicant
Monaghan Medical Corp.
Franklyn Bldg.
Rt. 9 N., P.O. Box 978
Plattsburgh,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
Monaghan Medical Corp.
Franklyn Bldg.
Rt. 9 N., P.O. Box 978
Plattsburgh,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/19/1985
Decision Date 11/18/1985
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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