510(k) K183311
K183311 is an FDA 510(k) premarket notification submitted by Ivenix, Inc. for the device "Ivenix Infusion System (IIS)". The FDA issued a decision of Substantially Equivalent on June 7, 2019. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Ivenix, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2019
- Date Received
- November 29, 2018
- 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