FDA device listing
Noninvasive ventilator breathing system
FDA device listing 2058072784 · Excellentcare Medical (Huizhou) Ltd.
Key facts
| Proprietary names | Noninvasive ventilator breathing system |
|---|---|
| Owner/operator | Excellentcare Medical (Huizhou) Ltd. |
| Owner/operator number | 10053236 |
| Product codes | BZO |
| Device names | BZO - Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5975 |
| Review panels | Anesthesiology |
| Registered establishments | Excellentcare Medical (Huizhou) Ltd. |
| Establishment registrations | 3013507143 |
| FEI numbers | 3013507143 |
| Establishment operations | 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