Skip to content

Je-228AK

by Nihon Kohden America, Inc.

Je-228AK is a Class II device made by Nihon Kohden America, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00841983102486), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841983102486 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Electroencephalograph
Model / Ref / Catalog
JE-228AK
Primary DI / UDI-DI
00841983102486
FDA product code
OLT
GMDN term
Electroencephalograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electroencephalograph

Other devices from Nihon Kohden America, Inc.

See all devices from Nihon Kohden America, Inc. →

Properties

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