510(k) K222404
K222404 is an FDA 510(k) premarket notification submitted by Neuroone Medical Technologies Corp. for the device "Evo® sEEG System". The FDA issued a decision of Substantially Equivalent on October 20, 2022. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Neuroone Medical Technologies Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2022
- Date Received
- August 9, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type