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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 K860488
Device Name OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
Applicant
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Applicant Contact COHEN, PHD
Correspondent
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Correspondent Contact COHEN, PHD
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/10/1986
Decision Date 08/25/1986
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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