Cleared Special

AcQMap High Resolution Imaging and Mapping System

K212345 · Acutus Medical, Inc. · Cardiovascular
Aug 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K212345 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 August 27, 2021, 30 days after receiving the submission on July 28, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K212345 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2021
Decision Date August 27, 2021
Days to Decision 30 days
Submission Type Special
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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