Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
FDA 510(k) K232793 · Zevex, Inc.
510(k) numberK232793
Submission
- Device name
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- Applicant
- Zevex, Inc.
Salt Lake City, UT, US - Received
- September 11, 2023
- Decision date
- May 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Special | 10/03/2024SE |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetPIF · Traditional | 01/08/2015SE |
| K131154 | Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral…LZH · Special | 02/12/2014SE |
| K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump UseKNT · Special | 11/02/2001SE |
Questions and answers
When was Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets cleared by the FDA?
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (K232793) received a 510(k) decision of Substantially Equivalent on May 17, 2024, 249 days after the submission was received.
What is the product code of K232793?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.