Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K252250
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) · Shanghai Draeger Medical Instrument Co., Ltd. · decided 2026-04-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Adapter cable Masimo/ Nellcor SpO2 Vista 300 | 2601008 | Shanghai Draeger Medical Instrument Co.,Ltd. | DSA | 04048675729655 |
| ECG trunk cable 12-lead SinglePin Vista300 | 2601963 | Shanghai Draeger Medical Instrument Co.,Ltd. | DSA | 04048675729631 |
| Vista 300 S | 2602426 | Shanghai Draeger Medical Instrument Co.,Ltd. | MHX | 04048675797180 |
| Masimo SpO2 Module for Vista 300/S | 2610044 | Shanghai Draeger Medical Instrument Co.,Ltd. | DQA | 04048675785910 |
| Vista 300 S | 2602425 | Shanghai Draeger Medical Instrument Co.,Ltd. | MHX | 04048675797173 |
| Vista 300 | 2601064 | Shanghai Draeger Medical Instrument Co.,Ltd. | MHX | 04048675723639 |
| Temp adapter Jack Vista 300 | 2600885 | Shanghai Draeger Medical Instrument Co.,Ltd. | DSA | 04048675746768 |
| Vista 300 S | 2602427 | Shanghai Draeger Medical Instrument Co.,Ltd. | MHX | 04048675797197 |
| Vista 300 | 2601065 | Shanghai Draeger Medical Instrument Co.,Ltd. | MHX | 04048675723646 |
| Vista 300 Sidestream CO2 Module | 2601068 | Shanghai Draeger Medical Instrument Co.,Ltd. | CCK | 04048675723677 |