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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K012451
Device Name PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
Applicant
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Applicant Contact DONALD M ABBEY
Correspondent
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Correspondent Contact DONALD M ABBEY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/01/2001
Decision Date 08/20/2001
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
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