WatchPAT ONE-M
Catalogue number WatchPAT ONE-M, listed by Itamar Medical, Israel, under Ventilatory Effort Recorder. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
15510(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 | Itamar Medical, Israel |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Manufacturer |
| 510(k) | K183559 |
| Record published | 2021-03-18 |
| Record revised | 2025-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 68.95 to 103.42 KiloPascal; Storage environment temperature 0 to 40 °C; Handling environment humidity 10 to 93 % RH; Handling environment temperature 0 to 40 °C; Storage environment atmospheric pressure 68.95 to 103.42 KiloPascal; Storage environment humidity 0 to 93 % RH |
| Packaging | Carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WatchPAT ONE-M | 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 |
| SOMNOtouch Resp accessory | Somnomedics AG | 18 |
| zRIP | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254042 | 2026-07-31 |
| K250460 | 2025-09-05 |
| K223675 | 2023-01-06 |
| K222331 | 2022-09-14 |
| K203839 | 2022-03-21 |
| K183559 | 2019-06-05 |
| K180775 | 2018-08-17 |
| K161579 | 2017-02-24 |
| K153070 | 2016-07-26 |
| K133859 | 2014-05-30 |
| K102567 | 2011-06-02 |
| K081982 | 2008-08-14 |
| K081037 | 2008-06-09 |
| K080427 | 2008-05-23 |
| K042916 | 2004-12-29 |
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.