K240509
- 510(k) number
- K240509
- Device name
- STAR Apollo Mapping System
- Applicant
- Rhythm AI, Ltd. GB
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-07-26
- Date received
- 2024-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240509.pdf
Official FDA record: K240509
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.