Cleared Traditional

Philips Holter Analysis System

K241890 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular
Mar 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K241890 is an FDA 510(k) clearance for the Philips Holter Analysis System, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Philips Medizin Systeme B?blingen GmbH (B?blingen, DE). The FDA issued a Cleared decision on March 21, 2025, 266 days after receiving the submission on June 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K241890 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2024
Decision Date March 21, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800

Similar Devices — MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 31
Frontier X Plus
K240794 · Fourth Frontier Technologies Pvt, Ltd. · Nov 2024
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833 · Vivaquant, Inc. · Sep 2020
CER-S
K193177 · Cardiocalm · Aug 2020
Faros Mobile
K182030 · Bittium Biosignals , Ltd. · Nov 2018
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · Labtech Kft. · Dec 2014
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · Vales & Hills Biomedical Tech. , Ltd. · Nov 2013

More from Philips Medizin Systeme...

View all
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K251702 · MHX · Nov 2025
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K250453 · MHX · Sep 2025
Telemetry Monitor 5500 Release 4.0 (867232)
K242962 · MHX · May 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
K243545 · DSA · Jan 2025
Cardiac Workstation (5000); Cardiac Workstation (7000)
K241556 · DPS · Dec 2024