FDA device listing
Fingertip Pulse Oximeter MD300CI218
FDA device listing 1448123488 · BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
Key facts
| Proprietary names | Fingertip Pulse Oximeter MD300CI218 |
|---|---|
| Owner/operator | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
| Owner/operator number | 9106400 |
| Premarket submissions | K181503 |
| Product codes | DQA |
| Device names | DQA - Oximeter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2700 |
| Review panels | Cardiovascular |
| Registered establishments | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD., Tianjin Choice Medical Device Co., Ltd. |
| Establishment registrations | 3005569927, 3015142815 |
| FEI numbers | 3005569927, 3015142815 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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