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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 K994423
Device Name AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
Applicant
Vsm Medtech , Ltd.
555 13th St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Vsm Medtech , Ltd.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/29/1999
Decision Date 03/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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