K200705 is an FDA 510(k) clearance for the Nurochek System. This device is classified as a Stimulator, Photic, Evoked Response (Class II - Special Controls, product code GWE).
Submitted by Cryptych Pty, Ltd. (North Sydney, AU). The FDA issued a Cleared decision on April 23, 2020, 36 days after receiving the submission on March 18, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1890.
| 510(k) Number | K200705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2020 |
| Decision Date | April 23, 2020 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWE - Stimulator, Photic, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1890 |