Cleared Traditional

HeartBeam AIMIGo(TM) System

K231424 · Heartbeam, Inc. · Cardiovascular
Dec 2024
Decision
576d
Days
Class 2
Risk

About This 510(k) Submission

K231424 is an FDA 510(k) clearance for the HeartBeam AIMIGo(TM) System, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Heartbeam, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 13, 2024, 576 days after receiving the submission on May 17, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K231424 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2023
Decision Date December 13, 2024
Days to Decision 576 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MWJ — Electrocardiograph, Ambulatory (without Analysis)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800