FDA device listing
AG-920RA,AG-920RA Mulitgas Unit
FDA device listing 1452785610 · NIHON KOHDEN CORP.
Key facts
| Proprietary names | AG-920RA,AG-920RA Mulitgas Unit |
|---|---|
| Owner/operator | NIHON KOHDEN CORP. |
| Owner/operator number | 8030227 |
| Premarket submissions | K020046 |
| Product codes | CBQ, CBR, CBS, CCK, CCL, NHO, NHP, NHQ |
| Device names | CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, CCL - Analyzer, Gas, Oxygen, Gaseous-Phase, NHO - Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration), NHP - Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration), NHQ - Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720 |
| Review panels | Anesthesiology |
| Registered establishments | NIHON KOHDEN AMERICA, INC., NIHON KOHDEN CORP., Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center, Nihon Kohden Tomioka Corporation |
| Establishment registrations | 2080783, 9611252, 3007962724, 3013501110 |
| FEI numbers | 2080783, 3002807720, 3007962724, 3013501110 |
| 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