Cleared Traditional

K152915 - EYE-SYNC (FDA 510(k) Clearance)

K152915 · Syncthink, Inc. · Neurology device
Jan 2016
Decision
119d
Days
Class 2
Risk

K152915 is an FDA 510(k) clearance for the EYE-SYNC. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).

Submitted by Syncthink, Inc. (Boston, US). The FDA issued a Cleared decision on January 29, 2016, 119 days after receiving the submission on October 2, 2015.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K152915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date January 29, 2016
Days to Decision 119 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWN - Nystagmograph
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.1460