waveguard CS-312
by eemagine Medical Imaging Solutions GmbH
waveguard CS-312 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 17 May 2017 (UDI-DI B195CS312), 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 | NumberB195CS312 | Date17 May 2017 | 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 B195CS312 listed 17 May 2017 Listed
Timeline
- Cleared FDA 510(k) K110223
- Listed FDA GUDID B195CS312
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- Withdrawn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
- CS-312
- Primary DI / UDI-DI
- B195CS312
- 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
Similar devices
Other devices filed under FDA product code GXY (ELECTRODE, CUTANEOUS).
- GLOBALCARE ELECTRODE by Globalcare Intl., Inc.
- EM TENS WINDOW ELECTRODES by Electromed Intl., Ltd.
- EMPI, NMS/SUE CUTANEOUS ELECTRODE by Empi
- CEPTOR HESIVE by Med General
- BIOFLEX GARMENTS, ASSORTED MODELS by Bioflex, Inc.
- INSPIRSTAR GLOVE ELECTRODE by Inspirstar, Inc.
- LEAD-LOK REUSABLE TENS/ NMES ELECTRODES by Lead-Lok, Inc.
- DURADERM BUTTERFLY by Sentry Medical Products, Inc.
- BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 by Biomed Products
- NORTECH MODEL 86901000 ELECTRODE by Conmed Andover Medical, Inc.
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