Cleared Traditional

KardiaMobile 6L

K210753 · AliveCor, Inc. · Cardiovascular
Jun 2021
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K210753 is an FDA 510(k) clearance for the KardiaMobile 6L, 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 June 30, 2021, 107 days after receiving the submission on March 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K210753 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date June 30, 2021
Days to Decision 107 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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