FDA Registration
Active
🇺🇸 United States
Nihon Kohden NKV-440 Ventilator System
Reg #: 3014631252
·
FEI: 3014631252
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NIHON KOHDEN ORANGEMED, LLC
- Registration Number
- 3014631252
- FEI Number
- 3014631252
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1800 E. Wilshire Avenue
- City
- Santa Ana
- State
- CA
- ZIP
- 92705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222644
Owner / Operator
- Firm Name
- Nihon Kohden OrangeMed, LLC
- Operator Number
- 10059216
- Address
- 1800 E. Wilshire Avenue
- City
- Santa Ana
- State
- CA
- Postal Code
- 92705
- Country
- US
- Correspondent
- Sheryl Higgins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2023-06-01 |
Proprietary Names
Nihon Kohden NKV-440 Ventilator System
Establishment Types
Manufacture Medical Device