Cleared Traditional

AliveCor Heart Monitor

K142743 · AliveCor, Inc. · Cardiovascular
Jan 2015
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K142743 is an FDA 510(k) clearance for the AliveCor Heart Monitor, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 27, 2015, 125 days after receiving the submission on September 24, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K142743 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2014
Decision Date January 27, 2015
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

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