Catalogue number SOWE050-G, listed by Somnomedics AG, Germany, under Ventilatory Effort Recorder. 3 manufacturers in China are registered for 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.
Record
Regulatory record for SOMNOwatch® eco green | 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) | K081485 |
| Record published | 2026-07-15 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 15 to 90 % RH; Handling environment temperature 5 to 40 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal |
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.