K242660
- 510(k) number
- K242660
- Device name
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
- Applicant
- Zevex, Inc. UT · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2024-10-03
- Date received
- 2024-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K242660.pdf
Official FDA record: K242660
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.