Cleared Traditional

KardiaMobile, KardiaStation

K191406 · AliveCor, Inc. · Cardiovascular
Jan 2020
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K191406 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 January 24, 2020, 241 days after receiving the submission on May 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K191406 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2019
Decision Date January 24, 2020
Days to Decision 241 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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