Philips Holter Analysis System
FDA 510(k) K241890 · Philips Medizin Systeme Böblingen GmbH
510(k) numberK241890
Submission
- Device name
- Philips Holter Analysis System
- Applicant
- Philips Medizin Systeme Böblingen GmbH
Böblingen, DE - Received
- June 28, 2024
- Decision date
- March 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code MLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261580 | ZBPro Diagnostic (Version 2.0)MLO · Traditional | Zbeats, Inc. | 09/11/2026SE |
| K240794 | Frontier X PlusMLO · Traditional | Fourth Frontier Technologies Pvt, Ltd. | 11/08/2024SE |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional | VivaQuant, Inc. | 09/02/2020SE |
| K193177 | Cer-SMLO · Traditional | Cardiocalm | 08/26/2020SE |
| K182030 | Faros MobileMLO · Abbreviated | Bittium Biosignals , Ltd. | 11/08/2018SE |
| K140847 | Cardiospy ECG Holter SystemsMLO · Traditional | Labtech Kft. | 12/05/2014SE |
| K131897 | CV3000 Holter Analysis SystemMLO · Traditional | Vales & Hills Biomedical Tech. , Ltd. | 11/26/2013SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | Inovise Medical, Inc. | 10/11/2013SE |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | Inovise Medical, Inc. | 09/20/2012SE |
| K111487 | NH-301 Ambulatory ECG Analysis SoftwareMLO · Special | Norav Medical Corp. | 11/10/2011SE |
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| K242962 | Telemetry Monitor 5500 Release 4.0 (867232)MHX · Traditional | 05/05/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | 01/17/2025SE |
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| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)MHX · Traditional | 02/03/2023SE |
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Questions and answers
When was Philips Holter Analysis System cleared by the FDA?
Philips Holter Analysis System (K241890) received a 510(k) decision of Substantially Equivalent on March 21, 2025, 266 days after the submission was received.
What is the product code of K241890?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.