K243985
- 510(k) number
- K243985
- Device name
- Rio Drug Reconstitution Transfer Device
- Applicant
- Icu Medical, Inc. CA · US
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2025-01-22
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243985.pdf
Official FDA record: K243985
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.