FDA Registration
Active
🇺🇸 United States
SIMEOX 200 Airway Clearance Device
Reg #: 3019385742
·
FEI: 3009843463
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Inogen, Inc
- Registration Number
- 3019385742
- FEI Number
- 3009843463
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 600 Shiloh Rd.
- City
- Plano
- State
- TX
- ZIP
- 75074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241091
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 |
|---|---|---|---|---|---|
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | Class 2 | Anesthesiology | No | 2025-03-06 |
Proprietary Names
SIMEOX 200 Airway Clearance Device
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Manufacture Medical Device