Cleared Traditional

ALIVECOR HEART MONITOR FOR IPHONE

K122356 · AliveCor, Inc. · Cardiovascular
Nov 2012
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K122356 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR FOR IPHONE, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on November 19, 2012, 108 days after receiving the submission on August 3, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K122356 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2012
Decision Date November 19, 2012
Days to Decision 108 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