Cleared Traditional

ALIVECOR HEART MONITOR OTC

K130921 · AliveCor, Inc. · Cardiovascular
Feb 2014
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K130921 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR OTC, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 6, 2014, 309 days after receiving the submission on April 3, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K130921 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2013
Decision Date February 06, 2014
Days to Decision 309 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