Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K190131 · Acutus Medical, Inc. · Cardiovascular
Apr 2019
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K190131 is an FDA 510(k) clearance for the AcQMap High Resolution Imaging and Mapping System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 2, 2019, 64 days after receiving the submission on January 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K190131 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2019
Decision Date April 02, 2019
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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