Cleared Traditional

DeepRhythmAI

K210822 · Medicalgorithmics S.A. · Cardiovascular
Jul 2022
Decision
495d
Days
Class 2
Risk

About This 510(k) Submission

K210822 is an FDA 510(k) clearance for the DeepRhythmAI, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on July 27, 2022, 495 days after receiving the submission on March 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K210822 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2021
Decision Date July 27, 2022
Days to Decision 495 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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