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Flash Led Stimulator B9700063000

by Eb Neuro SpA

Flash Led Stimulator B9700063000 is a Class II device made by Eb Neuro SpA, cleared under FDA 510(k) K242832 on 12 Dec 2024 (2 earlier submissions) and listed in FDA GUDID since 10 Apr 2019 (UDI-DI 08056446900178), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK242832 Date12 Dec 2024DecidedStatusActive
United StatesGUDID listing Number08056446900178 UDI-DI Date10 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242832 decided 12 Dec 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08056446900178 listed 10 Apr 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K121996
  2. Listed FDA GUDID 08056446900178
  3. Cleared FDA 510(k) K242305
  4. Cleared FDA 510(k) K242832

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flash Led Stimulator
Generic name
Visual stimulator
Model / reference
B9700063000
Primary DI / UDI-DI
08056446900178
510(k) Number
FDA product code
GWE
GMDN term
Visual stimulator
Device class
Class II
Regulation number
882.1890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Visual stimulator

Cleared under the same submission (K121996)

and 6 more cleared under K121996

Cleared under the same submission (K242305)

and 7 more cleared under K242305

Similar devices

Other devices filed under FDA product code GWE (Stimulator, Photic, Evoked Response).

Other devices from Eb Neuro SpA

See all devices from Eb Neuro SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)