K241442
- 510(k) number
- K241442
- Device name
- eZSURE Empty Fluid Container with ProSeal Injection Site
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- KPE — Container, I.V.
- Decision date
- 2024-06-21
- Date received
- 2024-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K241442.pdf
Official FDA record: K241442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.