FDA device listing
Ultima High-Output PVDF Respiratory Effort Sensor,Ultima PVDF Respiratory Effort Sensor,ULTIMA RESPIRATORY EFFORT…
FDA device listing 1385117283 · BRAEBON MEDICAL CORP.
Key facts
| Proprietary names | Ultima High-Output PVDF Respiratory Effort Sensor,Ultima PVDF Respiratory Effort Sensor,ULTIMA RESPIRATORY EFFORT SENSORS,VALUELINE RESPIRATORY EFFORT SENSOR |
|---|---|
| Owner/operator | BRAEBON MEDICAL CORP. |
| Owner/operator number | 9041773 |
| Premarket submissions | K982216 |
| Product codes | BZQ |
| Device names | BZQ - Monitor, Breathing Frequency |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.2375 |
| Review panels | Anesthesiology |
| Registered establishments | BRAEBON MEDICAL CORP. |
| Establishment registrations | 3002912391 |
| FEI numbers | 3002912391 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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