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FDA 510(k) Application Details - K961014
Device Classification Name
System, Ecg Analysis
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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