K253021
- 510(k) number
- K253021
- Device name
- ANNE Maternal
- Applicant
- Sibel Health, Inc. IL · US
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2026-02-26
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253021.pdf
Official FDA record: K253021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.