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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 K860287
Device Name PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
Applicant
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Applicant Contact BALZER, JR.
Correspondent
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Correspondent Contact BALZER, JR.
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/28/1986
Decision Date 04/28/1986
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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