Skip to content

Cardiologs Holter Platform

by Philips France Commercial

510(k) K250569

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250569↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250569 Date6 Aug 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardiologs Holter Platform is a diagnostic device designed for continuous ambulatory electrocardiographic (Holter) monitoring. It records and analyzes long-term ECG data to detect and evaluate cardiac arrhythmias, providing clinicians with detailed insights into heart rhythm abnormalities over extended periods. This platform supports automated analysis of ECG signals, enhancing diagnostic accuracy and efficiency for cardiovascular assessments.

The device is supplied as a cloud-based solution, integrating AI-driven algorithms to streamline Holter ECG analysis. It is intended for single-use or reusable components depending on the specific modules, with regulatory clearance under FDA 510(k) (K250569) and MDR compliance. The system is intended for use in clinical settings, including hospitals and diagnostic centers, where continuous cardiac monitoring is required. No specific sterility or MRI safety information is provided in the data.