Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
Zevex, Inc. · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Salt Lake City
- Advisory committee description
- General Hospital
- Address 1
- 4314 Zevex Park Ln.,
- Statement or summary
- Summary
- Product code
- FRN
- Zip code
- 84123
- Applicant
- Zevex, Inc.
- Decision date
- 2024-05-17
- Decision code
- SESE
- Country code
- US
- Device name
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- Advisory committee
- HO
- Contact
- Christopher Dodge
- K number
- K232793
- State
- UT
- Date received
- 2023-09-11
- Review advisory committee
- HO
- Postal code
- 84123
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Pump, Infusion
- Medical specialty description
- General Hospital
- Regulation number
- 880.5725
- Device class
- 2
- Registration number
- 1526611, 1055927, 2320968, 2027804, 3018094310, 3008058400, 3013298431, 9617594, 3003927385, 3009456923, 3005382983, 3011688490, 2029015, 3012302888, 2244478, 9617787, 1061124, 1314417, 1054713, 3004548776, 3013764800, 3010564249, 1320894, 2024022, 2523676, 9610825, 9681819, 1921846, 3007738736, 9680425, 3006534321, 9680741, 3020777588, 1018470, 3013722099, 1220973, 3000240707, 3004112621, 3009754410, 3016798778 +108 more
- FEI number
- 1526611, 3018094310, 3008058400, 3013298431, 3003927385, 1000113359, 3003282181, 1000160458, 3009456923, 3005382983, 3011688490, 3012302888, 1314417, 3004548776, 3000957797, 3000206435, 3001236905, 3013764800, 3010564249, 3002826093, 3003166194, 2648209, 1000138054, 2024022, 3003076831, 2523676, 1921846, 3000147578, 3007738736, 3006534321, 3020777588, 3002879021, 1018470, 3003767881, 3013722099, 3002807099, 3003513491, 1220973, 3000240707, 3004112621 +108 more