Watch-PAT300
The Watch-PAT300 is a home sleep assessment device for patients with suspected sleep-related breathing disorders. It records peripheral arterial tone and oxygen saturation through a finger…
The Watch-PAT300 is a home sleep assessment device for patients with suspected sleep-related breathing disorders. It records peripheral arterial tone and oxygen saturation through a finger probe, along with wrist movement from an internal activity sensor.
The wrist-worn controller records these signals for analysis of breathing disturbance indices and sleep stages. An optional external sensor adds snoring and body position data, with chest movement available from the RESBP sensor.
Listed Item
Watch-PAT300 Device
Patient Limits
General parameters are intended for patients aged 12 and older. The central apnea index, pAHIc, is intended for those aged 17 and older. The system is a diagnostic aid, with its results used to determine whether further sleep assessment is warranted.
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) | K180775 |
| Record published | 2019-03-27 |
| Record revised | 2025-09-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 68.95 to 103.42 KiloPascal; 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; Storage environment temperature -20 to 40 °C |
| Packaging | Box, carton, carton of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Watch-PAT300 | In distribution | |
| Watch-PAT300 | In distribution | |
| Watch-PAT300 | 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.