K242111
- 510(k) number
- K242111
- Device name
- VIVACE
- Applicant
- Unimom.Co KR
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-02-06
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242111.pdf
Official FDA record: K242111
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.