K241227
- 510(k) number
- K241227
- Device name
- RHYTHMIA HDx Mapping System
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-08-29
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241227.pdf
Official FDA record: K241227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.