Identity
- Trade Name
- Flash Led Stimulator FDA UDI
- Generic Name
- Visual stimulator FDA UDI
- Device Name
- Flash Stimulator for EEG/EP/EMG FDA UDI
- Model / Reference
- B9700063000 FDA UDI
- Description
- Flash Stimulator for EEG/EP/EMG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900178 FDA UDI
- FDA Product Code
- GWE FDA UDI
- GMDN Term
- Visual stimulator 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Visual stimulator
Flash Led Stimulator by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Visual stimulator.
- SightSaverMini — Anschel Technology, Inc. · Class II
- Visual System HD — Nordicneurolab · Class II
- Coil Mounted Display — Nordicneurolab · Class II
- LCD Power Supply — Nordicneurolab · Class II
- LCD Power Supply — Nordicneurolab · Class II
- Inroom Viewing Device — Nordicneurolab · Class II
- Visual System Power Supply — Nordicneurolab · Class II
- Visual Stimulation Box — Intelligent Hearing Systems Corp. · Class II
Cleared under the same submission
K121996 also covers:
- BE PLUS LTM — EB NEURO SPA
- BE PLUS LTM — EB NEURO SPA
- BE PLUS LTM Battery Pack — EB NEURO SPA
- BE PLUS LTM PLUG-IN HEADBOX, 32-CHANNELS — EB NEURO SPA
- BE PLUS LTM PLUG-IN HEADBOX, 64-CHANNELS — EB NEURO SPA
- BE PLUS LTM PLUG-IN HEADBOX, 64CH (129-192) — EB NEURO SPA
- BE PLUS LTM PLUG-IN HEADBOX, 64CH (193-256) — EB NEURO SPA
- BE PLUS LTM PLUG-IN HEADBOX, 64CH (65-128) — EB NEURO SPA
- BE PLUS LTM PULSE OXIMETER — EB NEURO SPA
- Battery Charger — EB NEURO SPA
K242305 also covers:
- BE PLUS LTM PULSE OXIMETER — EB NEURO SPA
- BE PLUS PRO ADVANCED — EB NEURO SPA
- BE PLUS PRO Battery Pack — EB NEURO SPA
- BE PLUS PRO FULL — EB NEURO SPA
- BE PLUS PRO LIGHT — EB NEURO SPA
- BE PLUS PRO STANDARD — EB NEURO SPA
- Battery Charger — EB NEURO SPA
- Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA
- Neurotravel LIGHT Base Unit — EB NEURO SPA
- USB FLASH ADAPTER CABLE L=3m — EB NEURO SPA
- USB FLASH ADAPTER CABLE L=5m — 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 e4c7ad37-dbef-4528-9bda-c6d02903fa7d 35 fields · synced May 31, 2026