Identity
- Trade Name
- BE PLUS LTM FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- EEG Amplifier FDA UDI
- Model / Reference
- B9700082000 FDA UDI
- Description
- EEG Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900086 FDA UDI
- 510(k) Number
- K121996 FDA UDI
- FDA Product Code
- GWL FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 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: ElectroencephalographEvoked-potential graphic recording system
Be Plus Ltm by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121996 also covers:
- 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
- Flash Led Stimulator — 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 d9facf66-4621-478d-a8f9-e17b928db20b 35 fields · synced Jun 8, 2026