Cleared Traditional

MoMe Software Platform

K152491 · Infobionic, Inc. · Cardiovascular
Dec 2015
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K152491 is an FDA 510(k) clearance for the MoMe Software Platform, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Infobionic, Inc. (Lowell, US). The FDA issued a Cleared decision on December 17, 2015, 107 days after receiving the submission on September 1, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K152491 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2015
Decision Date December 17, 2015
Days to Decision 107 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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