K240305
- 510(k) number
- K240305
- Device name
- ANNE Limb
- Applicant
- Sibel Health, Inc. IL · US
- Product code
- DQA — Oximeter
- Decision date
- 2024-05-28
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240305.pdf
Official FDA record: K240305
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.