FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K Number: K201931
·
Decision Oct 2, 2021
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
31
Applicant Total
3
Review Days
446
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Basic Information
- Device Name
- Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
- K Number
- K201931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dixi Medical
- Date Received
- July 13, 2020
- Decision Date
- October 2, 2021
- Product Code
- GYC
- 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 |
|---|---|---|---|
| GYC | Electrode, Cortical | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYC), ordered by most recent decision date.
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
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