K250569
- 510(k) number
- K250569
- Device name
- Cardiologs Holter Platform
- Applicant
- Philips France Commercial FR
- Product code
- DPS — Electrocardiograph
- Decision date
- 2025-08-06
- Date received
- 2025-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250569.pdf
Official FDA record: K250569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.