SOMNOtouch Resp Accessory
18 catalogue numbers from TOS805, listed by Somnomedics AG, Germany, under Ventilatory Effort Recorder. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
18catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Somnomedics AG, Germany |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K140861 |
| Record published | 2016-09-19 |
| Record revised | 2025-02-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TOS805 | In distribution | |
| TOS011 | In distribution | |
| TOS802 | In distribution | |
| TOS110S | In distribution | |
| TOS807 | In distribution | |
| TOS800 | In distribution | |
| TOS060 | In distribution | |
| TOS803 | In distribution | |
| TOS175S | In distribution | |
| TOS010 | In distribution | |
| TOS801 | In distribution | |
| TOS020 | In distribution | |
| TOS806 | In distribution | |
| TOS011S | In distribution | |
| TOS062 | In distribution | |
| TOS012 | In distribution | |
| TOS808 | In distribution | |
| TOS095 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleepsense | S. L. P. Scientific Laboratory Products Ltd | 182 |
| TriplePlay | Dymedix Diagnostics Inc | 71 |
| Embla | S. L. P. Scientific Laboratory Products Ltd | 36 |
| Grass | S. L. P. Scientific Laboratory Products Ltd | 31 |
| Xltek | Embla Systems | 30 |
| Alice NightOne | Respironics Inc. | 22 |
| Onera STS | Onera B.V. | 21 |
| Natus | S. L. P. Scientific Laboratory Products Ltd | 21 |
| Night Shift | Advanced Brain Monitoring, Inc. | 19 |
| Neurovirtual | Neurovirtual USA, Inc. | 18 |
| zRIP | Respironics Inc. | 17 |
| Alice PDx | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140861 | 2015-01-30 |
| K081485 | 2008-09-18 |
| K071556 | 2007-07-18 |
| K060708 | 2007-01-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.