510(k) K223674
K223674 is an FDA 510(k) premarket notification submitted by Epic Medical Pte. , Ltd. for the device "eZSURE Empty Fluid Container (models 426030, 426040, 426110)". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Epic Medical Pte. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2023
- Date Received
- December 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type