EyeStat— 510(k) K191700

Substantially Equivalent

Blinktbi, Inc.

FDA 510(k) clearance K191700 for EyeStat, Substantially Equivalent on 2019-12-09. Applicant: Blinktbi, Inc..

Clearance details

Applicant: Blinktbi, Inc.
Product code: Code GZP
Advisory panel: Neurology
Date received: 2019-06-25
Decision date: 2019-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.