K250777
- 510(k) number
- K250777
- Device name
- Sonicaid Team3
- Applicant
- Huntleigh Healthcare , Ltd. GB
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2025-09-19
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250777.pdf
Official FDA record: K250777
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.