FDA device listing
ORG-9100A
FDA device listing 1692122699 · NIHON KOHDEN CORP.
Key facts
| Proprietary names | ORG-9100A |
|---|---|
| Owner/operator | NIHON KOHDEN CORP. |
| Owner/operator number | 8030227 |
| Product codes | KMI |
| Device names | KMI - Monitor, Bed Patient |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.2400 |
| Review panels | General Hospital |
| Registered establishments | NIHON KOHDEN AMERICA, INC., NIHON KOHDEN CORP., Nihon Kohden Corporation - Eastern Japan Logistics Center, Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center |
| Establishment registrations | 2080783, 9611252, 3013501110, 3016852448 |
| FEI numbers | 2080783, 3002807720, 3013501110, 3016852448 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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