FDA device listing
SpO2 Sensor
FDA device listing 1352523011 · Shenzhen Upnmed Equipment Co., Ltd.
Key facts
| Proprietary names | SpO2 Sensor |
|---|---|
| Owner/operator | Shenzhen Upnmed Equipment Co., Ltd. |
| Owner/operator number | 10096254 |
| Premarket submissions | K183277 |
| Product codes | DQA |
| Device names | DQA - Oximeter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2700 |
| Review panels | Cardiovascular |
| Registered establishments | SHENZHEN UPNMED EQUIPMENT CO., LTD. |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- None Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database