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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K911871
Device Name CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS
Applicant
Cardiodyne, Inc.
95 Clinton Rd.
Brookline,  MA  02146
Applicant Contact PATRICK PHILLIPS
Correspondent
Cardiodyne, Inc.
95 Clinton Rd.
Brookline,  MA  02146
Correspondent Contact PATRICK PHILLIPS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/26/1991
Decision Date 11/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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