EYE-SYNC— 510(k) K152915

Substantially Equivalent

Syncthink, Inc.

FDA 510(k) clearance K152915 for EYE-SYNC, Substantially Equivalent on 2016-01-29. Applicant: Syncthink, Inc.. Device class: 2.

Clearance details

Applicant: Syncthink, Inc.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2015-10-02
Decision date: 2016-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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