Cleared Traditional

AliveCor QT Service

K212662 · AliveCor, Inc. · Cardiovascular
Apr 2022
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K212662 is an FDA 510(k) clearance for the AliveCor QT Service, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 26, 2022, 246 days after receiving the submission on August 23, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K212662 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2021
Decision Date April 26, 2022
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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