K250932
- 510(k) number
- K250932
- Device name
- DeepRhythmAI
- Applicant
- Medicalgorithmics S.A. PL
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-05-27
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250932.pdf
Official FDA record: K250932
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.