K241197
- 510(k) number
- K241197
- Device name
- DeepRhythmAI
- Applicant
- Medicalgorithmics S.A. PL
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-12-04
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241197.pdf
Official FDA record: K241197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.