Cleared Special

KardiaMobile Card

K211668 · AliveCor, Inc. · Cardiovascular
Nov 2021
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K211668 is an FDA 510(k) clearance for the KardiaMobile Card, 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 November 30, 2021, 182 days after receiving the submission on June 1, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K211668 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2021
Decision Date November 30, 2021
Days to Decision 182 days
Submission Type Special
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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