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FDA 510(k) Application Details - K152160
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K152160
Device Name
Computer, Diagnostic, Programmable
Applicant
APN Health, LLC
4900 Hopyard Road, Suite 100
Pleasanton, CA 94588 US
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Contact
David Geddam
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2015
Decision Date
02/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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