waveguard CA-069
by eemagine Medical Imaging Solutions GmbH
waveguard CA-069 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 2 Mar 2021 (UDI-DI B195CA069), 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 | NumberB195CA069 | Date2 Mar 2021 | 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 B195CA069 listed 2 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K110223
- Listed FDA GUDID B195CA069
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- Withdrawn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-069
- Primary DI / UDI-DI
- B195CA069
- 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).
- SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS by The Electrode Store
- REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD by Pioneering Technologies, Inc.
- Conductor Disposable TENS Electrode by Medical Science Products, Inc.
- Wavi Headset and Wavi eSoc Single Use Electrode Contacts by Wavi Co.
- ZMI Self-Adhesive Electrodes by Zmi Elecronics, Ltd.
- Empi Single Use by Empi
- DOCXS B SERIES ELECTRODES by Docxs, LLC
- Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) by ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
- LifeCare Conductive Garments by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- MODEL 4310 PSARRAY2 EEG ELECTRODE by Physiometrix, Inc.
Other devices from eemagine Medical Imaging Solutions GmbH
See all devices from eemagine Medical Imaging Solutions GmbH →