FDA Registration
Active
🇺🇸 United States
AG-920RA Mulitgas Unit
Reg #: 2080783
·
FEI: 2080783
·
Expires 2025
Products
8
Proprietary Names
2
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- NIHON KOHDEN AMERICA, INC.
- Registration Number
- 2080783
- FEI Number
- 2080783
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 15353 Barranca Pkwy
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020046
Owner / Operator
- Firm Name
- NIHON KOHDEN CORP.
- Operator Number
- 8030227
- Address
- 1-31-4 NISHIOCHIAI, SHINJUKU-KU
- City
- TOKYO
- State
- JP-13
- Postal Code
- 161-8560
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2007-11-28 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2007-11-28 |
Proprietary Names
AG-920RA Mulitgas Unit
AG-920RA
Establishment Types
Complaint File Establishment per 21 CFR 820.198