The following data is part of a premarket notification filed by Blinktbi Inc. with the FDA for Eyestat.
| Device ID | K191700 |
| 510k Number | K191700 |
| Device Name: | EyeStat |
| Classification | Stimulator, Mechanical, Evoked Response |
| Applicant | Blinktbi Inc. 635 Rutledge Ave., Suite 102 Charleston, SC 29403 |
| Contact | Ryan Fiorini |
| Correspondent | S. Mathur S Mathur 635 Rutledge Ave, Suite 102 Charleston, SC 29403 |
| Product Code | GZP |
| CFR Regulation Number | 882.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2019-12-09 |