FDA 510(k) Application Details - K022453

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K022453
Device Name Detector And Alarm, Arrhythmia
Applicant WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON, OR 97008-7107 US
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Contact DON M ABBEY
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 07/26/2002
Decision Date 08/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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