Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K210680 · Acutus Medical, Inc. · Cardiovascular
Aug 2021
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K210680 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 5, 2021, 150 days after receiving the submission on March 8, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K210680 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2021
Decision Date August 05, 2021
Days to Decision 150 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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