K251512
- 510(k) number
- K251512
- Device name
- Hi bebe super (BT-150B)
- Applicant
- Bistos Co., Ltd. KR
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-09-25
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251512.pdf
Official FDA record: K251512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.