FDA 510(k) Application Details - K961014

Device Classification Name System, Ecg Analysis

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510(K) Number K961014
Device Name System, Ecg Analysis
Applicant QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021-8906 US
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Contact MATT HEDLUND
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 03/13/1996
Decision Date 07/31/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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