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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 K950249
Device Name VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205
Applicant
MEDWAVE, INC.
SUITE 6
1410 ENERGY PARK DRIVE
ST. PAUL,  MN  55108
Applicant Contact . K ARCHIBALD
Correspondent
MEDWAVE, INC.
SUITE 6
1410 ENERGY PARK DRIVE
ST. PAUL,  MN  55108
Correspondent Contact . K ARCHIBALD
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/20/1995
Decision Date 02/01/1995
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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