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FDA 510(k) Application Details - K032038
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
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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