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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 K033378
Device Name VITAL SIGNS MONITOR, PROPAQ LT
Applicant
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Applicant Contact DAVE KLEMENTOWSKI
Correspondent
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Correspondent Contact DAVE KLEMENTOWSKI
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/22/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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