K250234
- 510(k) number
- K250234
- Device name
- SMARTeZ Elastomeric Infusion Pump (RS series)
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- MEB — Pump, Infusion, Elastomeric
- Decision date
- 2026-04-24
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250234.pdf
Official FDA record: K250234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.