510(k) K213744
K213744 is an FDA 510(k) premarket notification submitted by Eitan Medical , Ltd. for the device "Avoset Infusion Pump System". The FDA issued a decision of Substantially Equivalent on March 10, 2023. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2023
- Date Received
- November 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type