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FDA 510(k) Application Details - K220784
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K220784
Device Name
Computer, Diagnostic, Programmable
Applicant
Acutus Medical, Inc.
2210 Faraday Ave, Suite 100
Carlsbad, CA 92008 US
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Contact
Sindhu Sridhar
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
03/17/2022
Decision Date
07/01/2022
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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