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FDA 510(k)

EyeStat

K-Number: K191700 · 2019-12-09

ApplicantBlinktbi, Inc.
Decision Date2019-12-09
Product CodeGZP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EyeStat is a medical device manufactured by Blinktbi, Inc.. It received FDA 510(k) clearance on 2019-12-09 under approval number K191700. The device is classified under product code GZP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeStat?

EyeStat is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Blinktbi, Inc.. The 510(k) number is K191700.

When was EyeStat approved by the FDA?

EyeStat received FDA 510(k) clearance on 2019-12-09, under approval number K191700.

What company makes EyeStat?

EyeStat is manufactured by Blinktbi, Inc..

What is the FDA product code for EyeStat?

The FDA product code for EyeStat is GZP.

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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