FDA 510(k) Application Details - K032038

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K032038
Device Name Computer, Diagnostic, Programmable
Applicant QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021-8906 US
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Contact KAREN BROWNE
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 07/01/2003
Decision Date 09/05/2003
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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