Neurovirtual Maxxi Gold AgCl Electrode 96"
by Neurovirtual USA, Inc. 2 variants
Neurovirtual Maxxi Gold AgCl Electrode 96" (SI2138) is an analytical non-scalp cutaneous electrode (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Neurovirtual USA, Inc., cleared under FDA 510(k) K163547 on 11 Apr 2017 and listed in FDA GUDID since 1 Feb 2022 (UDI-DI 00850008393365), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850008393365 | Date1 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163547 | Date11 Apr 2017 | StatusActive |
Official records
- AccessGUDID record 00850008393365
- FDA 510(k) database K163547
Across registries
- FDA 510(k) K163547 decided 11 Apr 2017 Active
- FDA GUDID UDI-DI 00850008393365 listed 1 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K163547
- Listed FDA GUDID 00850008393365
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neurovirtual
- Generic name
- Analytical non-scalp cutaneous electrode
- Model / Ref / Catalog
- Maxxi Gold AgCl Electrode 96", SI2138
- Primary DI / UDI-DI
- 00850008393365
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical non-scalp cutaneous electrode
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Analytical non-scalp cutaneous electrode.