K191700 is an FDA 510(k) clearance for the EyeStat. This device is classified as a Stimulator, Mechanical, Evoked Response (Class II - Special Controls, product code GZP).
Submitted by Blinktbi, Inc. (Charleston, US). The FDA issued a Cleared decision on December 9, 2019, 167 days after receiving the submission on June 25, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1880.
| 510(k) Number | K191700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2019 |
| Decision Date | December 09, 2019 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZP - Stimulator, Mechanical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1880 |