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waveguard CA-104

by eemagine Medical Imaging Solutions GmbH

waveguard CA-104 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 18 Jan 2017 (UDI-DI B195CA104), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K110223

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB195CA104 UDI-DI Date18 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110223 Date29 Jun 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110223 decided 29 Jun 2011 Active
  • FDA GUDID UDI-DI B195CA104 listed 18 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110223
  2. Listed FDA GUDID B195CA104

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
waveguard
Generic name
Electroencephalographic electrode cap, reusable
Model / reference
CA-104
Primary DI / UDI-DI
B195CA104
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

Related devices

Category: Electroencephalographic electrode cap, reusable

Cleared under the same submission (K110223)

and 8 more cleared under K110223

Similar devices

Other devices filed under FDA product code GXY (ELECTRODE, CUTANEOUS).

Other devices from eemagine Medical Imaging Solutions GmbH

See all devices from eemagine Medical Imaging Solutions GmbH →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)