Cleared Abbreviated

MoMe? ARC Wireless Ambulatory ECG Monitoring and Detection System

K230265 · Infobionic, Inc. · Cardiovascular
Oct 2023
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K230265 is an FDA 510(k) clearance for the MoMe? ARC Wireless Ambulatory ECG Monitoring and Detection System, 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 October 6, 2023, 248 days after receiving the submission on January 31, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K230265 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2023
Decision Date October 06, 2023
Days to Decision 248 days
Submission Type Abbreviated
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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