K243976
- 510(k) number
- K243976
- Device name
- ZeroClear Bag Access (423100)
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2025-01-22
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243976.pdf
Official FDA record: K243976
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.