Cleared Traditional

EyeStat

K191700 · Blinktbi, Inc. · Neurology
Dec 2019
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K191700 is an FDA 510(k) clearance for the EyeStat, a Stimulator, Mechanical, Evoked Response (Class II — Special Controls, product code GZP), submitted by Blinktbi, Inc. (Charleston, US). The FDA issued a Cleared decision on December 9, 2019, 167 days after receiving the submission on June 25, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1880.

Submission Details

510(k) Number K191700 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2019
Decision Date December 09, 2019
Days to Decision 167 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZP — Stimulator, Mechanical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1880