Identity
- Trade Name
- SOMNOtouch RESP FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Model / Reference
- TOR050U FDA UDI
Identifiers
- Catalog Number
- TOR050U FDA UDI
- Primary DI / UDI-DI
- 04250413404612 FDA UDI
- 510(k) Number
- K140861 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Home-use sleep apnoea recording systemPolygraph
SOMNOtouch RESP by Somnomedics GmbH — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Polygraph.
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
- SOMNOtouch RESP Add-on device — Somnomedics GmbH
- SOMNOscreen plus EEG32 Tele Set — Somnomedics GmbH
- AASM Headbox — Somnomedics GmbH
- Simplified Sleep Stage Evaluation for SOMNOtouch RESP — Somnomedics GmbH
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
- 1-channel EEG option for SOMNOtouch RESP — Somnomedics GmbH · Class II
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
Cleared under the same submission
K140861 also covers:
- 1-channel EEG option for SOMNOtouch RESP — Somnomedics GmbH
- AASM Headbox — Somnomedics GmbH
- SOMNOtouch RESP Accessory — Somnomedics GmbH
- SOMNOtouch RESP Add-on device — Somnomedics GmbH
- SOMNOtouch RESP accessory — Somnomedics GmbH
- SOMNOtouch RESP accessory — Somnomedics GmbH
- SOMNOtouch RESP accessory — Somnomedics GmbH
- Simplified Sleep Stage Evaluation for SOMNOtouch RESP — Somnomedics GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140861 | Class II | Active |
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Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (2)
- FDA UDI c0411ffc-3265-4f8e-b9d3-778f5001aa1a 58 fields · synced Jun 18, 2026
- FDA 510(k) K140861 1 fields · synced Jun 4, 2026