FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Evo® sEEG System
K Number: K222404
·
Decision Oct 20, 2022
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
55
Applicant Total
3
Review Days
72
Basic Information
- Device Name
- Evo® sEEG System
- K Number
- K222404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NeuroOne Medical Technologies Corp.
- Date Received
- August 9, 2022
- Decision Date
- October 20, 2022
- Product Code
- GZL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZL | Electrode, Depth | FDA class 2 | Neurology |
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