K232793
- 510(k) number
- K232793
- Device name
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- Applicant
- Zevex, Inc. UT · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2024-05-17
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232793.pdf
Official FDA record: K232793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.