K202927 is an FDA 510(k) clearance for the EYE-SYNC. This device is classified as a Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (Class II - Special Controls, product code QEA).
Submitted by Syncthink, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 2, 2021, 368 days after receiving the submission on September 29, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1455. A Traumatic Brain Injury Eye Movement Assessment Aid Is A Prescription Device That Uses A Patients Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patients Brain. This Device Is An Assessment Aid That Is Not Intended For Standalone Detection Or Diagnostic Purposes..
| 510(k) Number | K202927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | October 02, 2021 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QEA - Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1455 |
| Definition | A Traumatic Brain Injury Eye Movement Assessment Aid Is A Prescription Device That Uses A Patients Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patients Brain. This Device Is An Assessment Aid That Is Not Intended For Standalone Detection Or Diagnostic Purposes. |