Devices · AliveCor, Inc.

KardiaAI

AliveCor, Inc. is listed for KardiaAI (K201985). The FDA list gives November 12, 2020 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DQK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201985

Official FDA database record

Date of final decision

November 12, 2020

Company on the FDA list

AliveCor, Inc.

Lead panel

Cardiovascular

Primary product code

DQK

openFDA device name for the code

Computer, Diagnostic, Programmable

Device class

2

Regulation number

870.1425

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary