Resbp for Watch-PAT200U
RESBP Sensor, Replacement - ROW
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) | K133859 |
| Record published | 2017-05-15 |
| Record revised | 2026-06-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 0 to 93 % RH; Storage environment temperature -20 to 40 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 68.95 to 103.42 KiloPascal; Handling environment temperature 0 to 40 °C; Handling environment atmospheric pressure 68.95 to 103.42 KiloPascal |
| Distribution end date | 2026-06-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RESBP for Watch-PAT200U | Withdrawn |
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.