EYE-SYNC— 510(k) K202927

Substantially Equivalent

Syncthink, Inc.

FDA 510(k) clearance K202927 for EYE-SYNC, Substantially Equivalent on 2021-10-02. Applicant: Syncthink, Inc.. Device class: 2.

Clearance details

Applicant: Syncthink, Inc.
Product code: Code QEA
Device class: Class 2
Regulation: 21 CFR 882.1455
Advisory panel: Neurology
Date received: 2020-09-29
Decision date: 2021-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Syncthink, Inc.

K152915 — EYE-SYNC2016-01-29

Recalls naming K202927

K-number listed on FDA's recall record

Z-2114-2025 — NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).Class II·Ongoing·NeuroSync, Inc.·20230919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202927.

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