Cleared Traditional

ALIVECOR HEART MONITOR

K130409 · AliveCor, Inc. · Cardiovascular
Sep 2013
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K130409 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 6, 2013, 199 days after receiving the submission on February 19, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K130409 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2013
Decision Date September 06, 2013
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340