Identity
- Trade Name
- Live View Panel Pro Version 2.0 FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- Live View Panel Pro Version 2.0 FDA UDI
- Model / Reference
- 2.0 FDA UDI
- Description
- Live View Panel Pro Version 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817111021264 FDA UDI
- 510(k) Number
- K131415 FDA UDI
- FDA Product Code
- GWQ FDA UDIOLZ FDA UDIOLV FDA UDIOLT FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioelectrical signal analysis softwareSleep disorder interpretive software, professional-only
Live View Panel Pro Version 2.0 by Neurotronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sleep disorder interpretive software, professional-only.
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- Noxturnal PSG CD — Nox Medical ehf. · Class II
- CASSIE — Tatch Inc. · Class II
- EnsoSleep PPG — Ensodata, Inc. · Class II
- DeepRESP — Nox Medical ehf. · Class II
Cleared under the same submission
K131415 also covers:
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
- Neurotronics, LLC
Sources (1)
- FDA UDI 7f5dbe98-74bd-4ee7-afc4-b1814a5409dd 34 fields · synced Jun 6, 2026