Goggles Stimulator Ii

FDA UDI

Class II (US FDA UDI)

by Eb Neuro Spa

Identity

Trade Name: GOGGLES STIMULATOR II FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Device Name: Lenses Module for Goggles Stimulator FDA UDI
Model / Reference: B9700091000 FDA UDI
Description: Lenses Module for Goggles Stimulator FDA UDI

Identifiers

Primary DI / UDI-DI: 08056446901038 FDA UDI
510(k) Number: K242832 FDA UDI
FDA Product Code: GWE FDA UDI
GMDN Term: Evoked-potential graphic recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential graphic recording system

Goggles Stimulator Ii by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Neuropack X1 — NIHON KOHDEN AMERICA, INC. · Class II

Cleared under the same submission

K242832 also covers:

Flash Led Stimulator — EB NEURO SPA
Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA
NExT-AMP — EB NEURO SPA
NExT-AMP-ADVANCED — EB NEURO SPA
NExT-AS — EB NEURO SPA
NExT-DOCKING — EB NEURO SPA
NExT-HS — EB NEURO SPA
NExT-PAD — EB NEURO SPA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Eb Neuro Spa

Sources (1)

FDA UDI 9de0483b-6c76-4d16-abd3-7e70dfde3c5f 35 fields · synced May 30, 2026