FDA device listing
airway flow sensors,Arkon
FDA device listing 1858115070 · SPACELABS HEALTHCARE, INC.
Key facts
| Proprietary names | airway flow sensors,Arkon |
|---|---|
| Owner/operator | SPACELABS HEALTHCARE, INC. |
| Owner/operator number | 2022906 |
| Premarket submissions | K113051 |
| Product codes | BSZ, CBK |
| Device names | BSZ - Gas-Machine, Anesthesia, CBK - Ventilator, Continuous, Facility Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5160, 868.5895 |
| Review panels | Anesthesiology |
| Registered establishments | Spacelabs Healthcare Inc., SPACELABS HEALTHCARE LTD. |
| Establishment registrations | 9611295, 3010157426 |
| FEI numbers | 3002807992, 3010157426 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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