FDA 510(k) Application Details - K041607

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K041607
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant QUINTON CARDIOLOGY, INC.
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021 US
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Contact KAREN BROWNE
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 06/15/2004
Decision Date 07/16/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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