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 IDK191392
510k NumberK191392
Device Name:AcQMap High Resolution Imaging And Mapping System
ClassificationComputer, Diagnostic, Programmable
Applicant Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
ContactKarla Schaffner
CorrespondentKarla Schaffner
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-24
Decision Date2019-09-06
Summary:summary

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