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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 K023078
Device Name BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR
Applicant
VSM MEDTECH LTD.
675 WEST HASTINGS ST., 15TH FL
VANCOUVER, B.C.,  CA V6B 1N2
Applicant Contact DARYL WISDAHL
Correspondent
VSM MEDTECH LTD.
675 WEST HASTINGS ST., 15TH FL
VANCOUVER, B.C.,  CA V6B 1N2
Correspondent Contact DARYL WISDAHL
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
FLL  
Date Received09/16/2002
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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