Cleared Traditional

KardiaMobile, KardiaStation

K182396 · AliveCor, Inc. · Cardiovascular
Apr 2019
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K182396 is an FDA 510(k) clearance for the KardiaMobile, KardiaStation, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 12, 2019, 220 days after receiving the submission on September 4, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K182396 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2018
Decision Date April 12, 2019
Days to Decision 220 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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