K242152
- 510(k) number
- K242152
- Device name
- SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- MEB — Pump, Infusion, Elastomeric
- Decision date
- 2024-10-07
- Date received
- 2024-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242152.pdf
Official FDA record: K242152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.