Identity
- Trade Name
- BE PLUS LTM PULSE OXIMETER FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Pulse oximeter for EEG Amplifier FDA UDI
- Model / Reference
- B9630082000 FDA UDI
- Description
- Pulse oximeter for EEG Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900161 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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: Pulse oximeter probe, reusable
Be Plus Ltm Pulse Oximeter by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- APK — Apk Technology · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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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
- Battery Charger — EB NEURO SPA
- Flash Led Stimulator — EB NEURO SPA
K242305 also covers:
- 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
- Flash Led Stimulator — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eb Neuro Spa
Sources (1)
- FDA UDI 3b829230-550a-4b0b-8d8c-3362af1f7e13 35 fields · synced Jun 8, 2026