Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
FDA 510(k) clearance K232793 · decided 2024-05-17
Clearance details
- K-number
- K232793
- Device name
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- Applicant
- Zevex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-11
- Decision date
- 2024-05-17
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.