Brain Atlas Cap-Small E1-Ba-Sm
by Electro-Cap International Inc
Brain Atlas Cap-Small E1-Ba-Sm is an analytical scalp lead (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Electro-Cap International Inc, cleared under FDA 510(k) K112319 on 27 Jan 2012 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00811478011074), active as of 22 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 | Number00811478011074 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112319 | Date27 Jan 2012 | StatusActive |
Official records
- AccessGUDID record 00811478011074
- FDA 510(k) database K112319
Across registries
- FDA 510(k) K112319 decided 27 Jan 2012 Active
- FDA GUDID UDI-DI 00811478011074 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K112319
- Listed FDA GUDID 00811478011074
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Brain Atlas Cap-Small
- Generic name
- Analytical scalp lead
- Model / Ref / Catalog
- E1-BA-SM
- Primary DI / UDI-DI
- 00811478011074
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical scalp lead
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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