Cleared Traditional

KardiaAI

K201985 · AliveCor, Inc. · Cardiovascular
Nov 2020
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K201985 is an FDA 510(k) clearance for the KardiaAI, 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 November 12, 2020, 118 days after receiving the submission on July 17, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K201985 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2020
Decision Date November 12, 2020
Days to Decision 118 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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