K251423
- 510(k) number
- K251423
- Device name
- Spectra S1 Pro; Spectra S2 Pro
- Applicant
- Uzinmedicare Co., Ltd. KR
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-02-06
- Date received
- 2025-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K251423.pdf
Official FDA record: K251423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.