FDA Registration
Active
🇺🇸 United States
OxyGo Fit BLUETOOTH
Reg #: 3004672275
·
FEI: 3004672275
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INOGEN, INC.
- Registration Number
- 3004672275
- FEI Number
- 3004672275
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 859 Ward Drive, Suite 200
- City
- Goleta
- State
- CA
- ZIP
- 93111
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032818
Owner / Operator
- Firm Name
- INOGEN, INC.
- Operator Number
- 9064201
- Address
- 859 Ward Drive, Suite 200
- City
- Goleta
- State
- CA
- Postal Code
- 93111
- Country
- US
- Correspondent
- Elias Cury
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2004-06-16 |
Proprietary Names
OxyGo Fit BLUETOOTH
INOGEN ONE OXYGEN CONCENTRATOR
OxyGo NEXT
INOGEN ONE G4 OXYGEN CONCENTRATOR
INOGEN ONE G5 OXYGEN CONCENTRATOR
INOGEN ONE G2 OXYGEN CONCENTRATOR
INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR
OxyGo
INOGEN ONE G3 OXYGEN CONCENTRATOR
OxyGo Fit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility