510(k) K250601
K250601 is an FDA 510(k) premarket notification submitted by Alpha Omega Engineering , Ltd. for the device "Neuro Omega System; NeuroSmart System". The FDA issued a decision of Substantially Equivalent on March 30, 2025. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Alpha Omega Engineering , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2025
- Date Received
- February 28, 2025
- Clearance Type
- Special
- 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