Skip to content

Discovery Discovery 20

by BrainMaster Technologies, Inc.

Ref 390-070Model Discovery 20

Discovery Discovery 20 (390-070) is a device classified as Class IIa in the EU and Class II in the US made by BrainMaster Technologies, Inc., registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI 0852391007EEG2X), cleared under FDA 510(k) K150498 on 26 Jan 2016 and listed in FDA GUDID since 15 Aug 2023 (UDI-DI 00852391007041), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150498

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0852391007EEG2X Basic UDI-DI 00852391007041UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00852391007041 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150498 Date26 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0852391007EEG2X registered 27 Jul 2026 Active
  • FDA 510(k) K150498 decided 26 Jan 2016 Active
  • FDA GUDID UDI-DI 00852391007041 listed 15 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150498
  2. Listed FDA GUDID 00852391007041
  3. Registered EUDAMED 0852391007EEG2X

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Discovery 20 EUDAMED
Discovery GUDID
Generic name
Electroencephalograph
Model / Ref / Catalog
Discovery 20, 390-070
Primary DI / UDI-DI
00852391007041
Basic UDI-DI
0852391007EEG2X
Direct marketing DI
00852391007041
510(k) Number
FDA product code
GWQ
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electroencephalograph

Cleared under the same submission (K150498)

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from BrainMaster Technologies, Inc.

See all devices from BrainMaster Technologies, Inc. →

Properties

  • Measuring function
  • Serial number
Other properties (23, all answered No)