IV-eye— 510(k) K152088

Substantially Equivalent

Novarix Limited

FDA 510(k) clearance K152088 for IV-eye, Substantially Equivalent on 2016-02-24. Applicant: Novarix Limited. Device class: 1.

Clearance details

Applicant
Novarix Limited
Product code
Code KZA
Device class
Class 1
Regulation
21 CFR 880.6970
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Abingdon, GB
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