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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K983250
Device Name INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
Applicant
Magnetic Resonance Equipment Corp.
6 Washington Ave.
Bay Shore,  NY  11706
Applicant Contact G.RONALD MORRIS
Correspondent
Magnetic Resonance Equipment Corp.
6 Washington Ave.
Bay Shore,  NY  11706
Correspondent Contact G.RONALD MORRIS
Regulation Number870.1110
Classification Product Code
DSK  
Date Received09/16/1998
Decision Date 12/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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