FDA device listing
Pulse Oximeter MD300K2 900-8275,Pulse Oximeter MD300M 16-834V2,Pulse Oximeter MD300M 16-835V2,Pulse Oximeter MD300M-G…
FDA device listing 1720178285 · LUXSHARE - ICT (NGHE AN) LIMITED
Key facts
| Proprietary names | Pulse Oximeter MD300K2 900-8275,Pulse Oximeter MD300M 16-834V2,Pulse Oximeter MD300M 16-835V2,Pulse Oximeter MD300M-G HCSMD400,SpO2 probe M-50B 16-2358,SpO2 probe M-50C 16-2350,SpO2 probe M-50E 16-2351,SpO2 probe M-50H 16-2356,SpO2 probe M-50J033 16-2352,SpO2 probe M-50J035 16-2354,SpO2 probe M-50J037 16-2353 |
|---|---|
| Owner/operator | LUXSHARE - ICT (NGHE AN ) LIMITED |
| Owner/operator number | 10093365 |
| Product codes | DQA |
| Device names | DQA - Oximeter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2700 |
| Review panels | Cardiovascular |
| Registered establishments | LUXSHARE - ICT (NGHE AN ) LIMITED |
| Establishment registrations | 3018514222 |
| FEI numbers | 3018514222 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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