K242125
- 510(k) number
- K242125
- Device name
- Elvie Stride 2
- Applicant
- Chiaro Technology, Ltd. GB
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2024-09-27
- Date received
- 2024-07-19
- 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: K242125.pdf
Official FDA record: K242125
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.