510(k) K152088
K152088 is an FDA 510(k) premarket notification submitted by Novarix Limited for the device "IV-eye". The FDA issued a decision of Substantially Equivalent on February 24, 2016. The device falls under product code KZA (Device, Vein Location, Liquid Crystal), a Class I device regulated under 21 CFR 880.6970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2016
- Date Received
- July 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vein Location, Liquid Crystal
- Device Class
- Class I
- Regulation Number
- 880.6970
- Review Panel
- HO
- Submission Type