FDA 510(k) Application Details - K021681

Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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510(K) Number K021681
Device Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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 870.2300

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Classification Product Code DRT
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Date Received 05/22/2002
Decision Date 07/23/2002
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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