FDA device listing
BESMED HEAD STRAP,Bonnet,Nasal mask
FDA device listing 1820800321 · BESMED HEALTH BUSINESS CORP.
Key facts
| Proprietary names | BESMED HEAD STRAP,Bonnet,Nasal mask |
|---|---|
| Owner/operator | BESMED HEALTH BUSINESS CORP. |
| Owner/operator number | 9047866 |
| Product codes | BTK |
| Device names | BTK - Strap, Head, Gas Mask |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5560 |
| Review panels | Anesthesiology |
| Registered establishments | Besmed Health Business Corporation, NINGBO BESMED MEDICAL EQUIPMENT CORP. |
| Establishment registrations | 9710567, 3006547005 |
| FEI numbers | 3003256355, 3006547005 |
| Establishment operations | Foreign Exporter, 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