510(k) K250234
K250234 is an FDA 510(k) premarket notification submitted by Epic Medical Pte. , Ltd. for the device "SMARTeZ Elastomeric Infusion Pump (RS series)". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Epic Medical Pte. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2026
- Date Received
- January 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type