K250208
- 510(k) number
- K250208
- Device name
- SPECTRA Wearable 2
- Applicant
- Uzinmedicare Co., Ltd. KR
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-04-06
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250208.pdf
Official FDA record: K250208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.