AcQMap High Resolution Imaging And Mapping System

Computer, Diagnostic, Programmable

Acutus Medical, Inc.

The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqmap High Resolution Imaging And Mapping System.

Pre-market Notification Details

Device IDK212345
510k NumberK212345
Device Name:AcQMap High Resolution Imaging And Mapping System
ClassificationComputer, Diagnostic, Programmable
Applicant Acutus Medical, Inc. 2210 Faraday Ave, Suite 100 Carlsbad,  CA  92008
ContactSindhu Sridhar
CorrespondentSindhu Sridhar
Acutus Medical, Inc. 2210 Faraday Ave, Suite 100 Carlsbad,  CA  92008
Product CodeDQK  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-28
Decision Date2021-08-27

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