510(k) K211367
K211367 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 September 1, 2021. 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
- September 1, 2021
- Date Received
- May 4, 2021
- 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