K232608
- 510(k) number
- K232608
- Device name
- Duo Hands-free Breast Pump
- Applicant
- Medela, LLC IL · US
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2024-04-12
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232608.pdf
Official FDA record: K232608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.