The following data is part of a premarket notification filed by Novarix Limited with the FDA for Iv-eye.
| Device ID | K152088 |
| 510k Number | K152088 |
| Device Name: | IV-eye |
| Classification | Device, Vein Location, Liquid Crystal |
| Applicant | Novarix Limited The Core Business Centre, Milton Hill Abingdon, GB Ox13 6ab |
| Contact | John Scott |
| Correspondent | Deirdre Barrow EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | KZA |
| CFR Regulation Number | 880.6970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-02-24 |
| Summary: | summary |