Cleared Traditional

DeepRhythm Platform

K232161 · Medicalgorithmics S.A. · Cardiovascular
Jun 2024
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K232161 is an FDA 510(k) clearance for the DeepRhythm Platform, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on June 20, 2024, 336 days after receiving the submission on July 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K232161 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2023
Decision Date June 20, 2024
Days to Decision 336 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340