AmplifEYE
K-Number: K160846 · 2016-07-14
ApplicantMedivators, Inc.
Decision Date2016-07-14
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AmplifEYE is a medical device manufactured by Medivators, Inc.. It received FDA 510(k) clearance on 2016-07-14 under approval number K160846. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AmplifEYE?
AmplifEYE is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Medivators, Inc.. The 510(k) number is K160846.
When was AmplifEYE approved by the FDA?
AmplifEYE received FDA 510(k) clearance on 2016-07-14, under approval number K160846.
What company makes AmplifEYE?
AmplifEYE is manufactured by Medivators, Inc..
What is the FDA product code for AmplifEYE?
The FDA product code for AmplifEYE is FED.
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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.