The following data is part of a premarket notification filed by Syncthink, Inc. with the FDA for Eye-sync.
| Device ID | K202927 |
| 510k Number | K202927 |
| Device Name: | EYE-SYNC |
| Classification | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Applicant | SyncThink, Inc. 2172 Staunton Court Palo Alto, CA 94306 |
| Contact | Dan Beeler |
| Correspondent | Allison Kumar Arina Consulting, LLC 27 Hilltop Dr San Carlos, CA 94070 |
| Product Code | QEA |
| CFR Regulation Number | 882.1455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-10-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EYE-SYNC 86425820 4743650 Live/Registered |
Sync-Think, Inc. 2014-10-16 |