waveguard CA-521
by eemagine Medical Imaging Solutions GmbH
waveguard CA-521 is an electroencephalographic electrode cap (FDA Class II; FDA product code GXY, Electrode, cutaneous) made by eemagine Medical Imaging Solutions GmbH, cleared under FDA 510(k) K110223 on 29 Jun 2011 and listed in FDA GUDID since 16 Dec 2025 (UDI-DI B195CA521), 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 | NumberB195CA521 | Date16 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110223 | Date29 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K110223
Across registries
- FDA 510(k) K110223 decided 29 Jun 2011 Active
- FDA GUDID UDI-DI B195CA521 listed 16 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K110223
- Listed FDA GUDID B195CA521
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- waveguard
- Generic name
- Electroencephalographic electrode cap, reusable
- Model / reference
- CA-521
- Primary DI / UDI-DI
- B195CA521
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Electroencephalographic electrode cap, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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