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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K022453
Device Name MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
Applicant
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact DON M ABBEY
Correspondent
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact DON M ABBEY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/26/2002
Decision Date 08/21/2002
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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