K240251
- 510(k) number
- K240251
- Device name
- ANNE Chest
- Applicant
- Sibel Health, Inc. IL · US
- Product code
- DRG — Transmitters And Receivers, Physiological Signal, Ra
- Decision date
- 2024-06-03
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240251.pdf
Official FDA record: K240251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.