510(k) K200705
K200705 is an FDA 510(k) premarket notification submitted by Cryptych Pty, Ltd. for the device "Nurochek System". The FDA issued a decision of Substantially Equivalent on April 23, 2020. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Cryptych Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2020
- Date Received
- March 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type