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 the device name listed in this FDA 510(k) record. The listed applicant is Novarix Limited. It received FDA 510(k) clearance on 2016-02-24 under 510(k) 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. The listed applicant is Novarix Limited. The 510(k) number is K152088.
When did IV-eye receive FDA 510(k) clearance?
IV-eye received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152088.
Who is the listed applicant for IV-eye?
The FDA 510(k) record lists Novarix Limited as the applicant. This does not by itself establish the device manufacturer.
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.