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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K063419
Device Name MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
Applicant
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact JEFFREY WAGNER
Correspondent
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact JEFFREY WAGNER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/13/2006
Decision Date 12/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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