EyeStat
K-Number: K191700 · 2019-12-09
ApplicantBlinktbi, Inc.
Decision Date2019-12-09
Product CodeGZP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EyeStat is the device name listed in this FDA 510(k) record. The listed applicant is Blinktbi, Inc.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) 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. The listed applicant is Blinktbi, Inc.. The 510(k) number is K191700.
When did EyeStat receive FDA 510(k) clearance?
EyeStat received FDA 510(k) clearance on 2019-12-09, under 510(k) number K191700.
Who is the listed applicant for EyeStat?
The FDA 510(k) record lists Blinktbi, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.