FDA device listing
INOGEN ONE G2 OXYGEN CONCENTRATOR,INOGEN ONE G3 OXYGEN CONCENTRATOR,INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR,INOGEN…
FDA device listing 1180946418 · INOGEN, INC.
Key facts
| Proprietary names | INOGEN ONE G2 OXYGEN CONCENTRATOR,INOGEN ONE G3 OXYGEN CONCENTRATOR,INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR,INOGEN ONE G4 OXYGEN CONCENTRATOR,INOGEN ONE G5 OXYGEN CONCENTRATOR,INOGEN ONE OXYGEN CONCENTRATOR,OxyGo,OxyGo Fit,OxyGo Fit BLUETOOTH,OxyGo NEXT |
|---|---|
| Owner/operator | INOGEN, INC. |
| Owner/operator number | 9064201 |
| Premarket submissions | K032818 |
| Product codes | CAW |
| Device names | CAW - Generator, Oxygen, Portable |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5440 |
| Review panels | Anesthesiology |
| Registered establishments | Inogen, Inc, INOGEN, INC. |
| Establishment registrations | 3004672275, 3019385742 |
| FEI numbers | 3004672275, 3009843463 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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