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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 K852459
Device Name HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
Applicant
Healthteam
625 Montrose Ave.
S. Plainfield,  NJ  07080
Applicant Contact JOHN CHAMBERS
Correspondent
Healthteam
625 Montrose Ave.
S. Plainfield,  NJ  07080
Correspondent Contact JOHN CHAMBERS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/10/1985
Decision Date 12/30/1985
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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