Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K181577 · Acutus Medical, Inc. · Cardiovascular
Feb 2019
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K181577 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 February 7, 2019, 237 days after receiving the submission on June 15, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K181577 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2018
Decision Date February 07, 2019
Days to Decision 237 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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