Identity
- Trade Name
- Neurovirtual FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- The Maxxi Snore Sensor is a device intended to acquire snore bursts FDA UDI
- Model / Reference
- Maxxi Snore 7ft Key connector FDA UDI
- Description
- The Maxxi Snore Sensor is a device intended to acquire snore bursts FDA UDI
Identifiers
- Catalog Number
- SI1784 FDA UDI
- Primary DI / UDI-DI
- 00850008393273 FDA UDI
- 510(k) Number
- K191095 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Unsafe FDA UDI
Category: Polysomnograph
Neurovirtual by Neurovirtual Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polysomnograph.
- Snore Sensor — Respironics, Inc. · Class II
- SleepmateSnoring Microphone — Ambu A/S · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
- TriplePlay — Dymedix Diagnostics, Inc. · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- micromed — Micromed, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
Cleared under the same submission
K191095 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
- Neurovirtual Usa, Inc.
Sources (1)
- FDA UDI b5a7f73a-d78f-454e-9371-2b47844fa5ef 36 fields · synced Jun 8, 2026