Cleared Traditional

Cardiologs Holter Platform

K250569 · Philips France Commercial · Cardiovascular
Aug 2025
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K250569 is an FDA 510(k) clearance for the Cardiologs Holter Platform, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Philips France Commercial (Paris, FR). The FDA issued a Cleared decision on August 6, 2025, 161 days after receiving the submission on February 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K250569 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2025
Decision Date August 06, 2025
Days to Decision 161 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