IV-eye
K-Number: K152088 · 2016-02-24
ApplicantNovarix Limited
Decision Date2016-02-24
Product CodeKZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
IV-eye is a medical device manufactured by Novarix Limited. It received FDA 510(k) clearance on 2016-02-24 under approval number K152088. The device is classified under product code KZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IV-eye?
IV-eye is a medical device that received FDA 510(k) clearance on 2016-02-24. It is manufactured by Novarix Limited. The 510(k) number is K152088.
When was IV-eye approved by the FDA?
IV-eye received FDA 510(k) clearance on 2016-02-24, under approval number K152088.
What company makes IV-eye?
IV-eye is manufactured by Novarix Limited.
What is the FDA product code for IV-eye?
The FDA product code for IV-eye is KZA.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.