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FDA 510(k)

AmplifEYE

K-Number: K160846 · 2016-07-14

ApplicantMedivators, Inc.
Decision Date2016-07-14
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AmplifEYE is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) 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. The listed applicant is Medivators, Inc.. The 510(k) number is K160846.

When did AmplifEYE receive FDA 510(k) clearance?

AmplifEYE received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160846.

Who is the listed applicant for AmplifEYE?

The FDA 510(k) record lists Medivators, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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