Nurochek System
by Cryptych Pty, Ltd. 510(k)
Active
510(k) K200705
Overview
The Nurochek System is a Stimulator, Photic, Evoked Response device classified under product code GWE and regulation number 882.1890. It is designed to deliver photic stimulation for the purpose of eliciting evoked neurological responses.
The device is supplied as a Class II medical device with Special Controls, having received FDA 510(k) clearance under K200705 on April 23, 2020. It is manufactured by Cryptych Pty, Ltd. in North Sydney, Australia, and is intended for use in neurology settings as indicated by the advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200705 | Date23 Apr 2020 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GWE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cryptych Pty, Ltd.
Questions
What is the Nurochek System used for?
The Nurochek System is designed to deliver photic stimulation for the purpose of eliciting evoked neurological responses. It is intended for use in neurology settings as indicated by the advisory committee classification.
How is the Nurochek System supplied and what is its regulatory status?
The device is supplied as a Class II medical device with Special Controls, having received FDA 510(k) clearance under K200705 on April 23, 2020. It is manufactured by Cryptych Pty, Ltd. in North Sydney, Australia.
What classification and product code apply to the Nurochek System?
The Nurochek System is classified under product code GWE and regulation number 882.1890 as a Stimulator, Photic, Evoked Response device. It received a traditional 510(k) clearance with a substantially equivalent decision.