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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 K881003
Device Name DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
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 Received03/09/1988
Decision Date 05/18/1988
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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