Cleared Traditional

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

K193310 · Abbott (St. Jude Medical) · Cardiovascular

Mar 2020

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K193310 is an FDA 510(k) clearance for the myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS), a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II — Special Controls, product code MXC), submitted by Abbott (St. Jude Medical) (Sylamr, US). The FDA issued a Cleared decision on March 17, 2020, 109 days after receiving the submission on November 29, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K193310 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2019
Decision Date	March 17, 2020
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2800