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 |