The following data is part of a premarket notification filed by Cryptych Pty Ltd with the FDA for Nurochek System.
| Device ID | K200705 |
| 510k Number | K200705 |
| Device Name: | Nurochek System |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | Cryptych Pty Ltd Level 15, Suite 1502, 275 Alfred Street North Sydney, AU 2060 |
| Contact | Angela Roche |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-04-23 |