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FDA 510(k) Application Details - K201094
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K201094
Device Name
Computer, Diagnostic, Programmable
Applicant
CardioNXT, Inc.
12011 Tejon Street, Suite 700
Westminster, CO 80234 US
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Contact
Kirk Mackin
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2020
Decision Date
08/16/2021
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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