K241890
- 510(k) number
- K241890
- Device name
- Philips Holter Analysis System
- Applicant
- Philips Medizin Systeme Böblingen GmbH DE
- Product code
- MLO — Electrocardiograph, Ambulatory, With Analysis Algori
- Decision date
- 2025-03-21
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241890.pdf
Official FDA record: K241890
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.