Cleared Traditional

MoMe ARC? Wireless Ambulatory ECG Monitoring and Detection System (32000)

K250356 · Infobionic, Inc. · Cardiovascular
Jul 2025
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K250356 is an FDA 510(k) clearance for the MoMe ARC? Wireless Ambulatory ECG Monitoring and Detection System (32000), a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Infobionic, Inc. (Chelmsford, US). The FDA issued a Cleared decision on July 29, 2025, 172 days after receiving the submission on February 7, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K250356 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2025
Decision Date July 29, 2025
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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