FDA device listing
ECG Trunk cables and leadwires, Trunk Cables(IBP cables, Spo2 cables, Temp. Cables), Adapter cables, Adaptors,,Leg plate…
FDA device listing 1270959048 · Orantech Inc.
Key facts
| Proprietary names | ECG Trunk cables and leadwires, Trunk Cables(IBP cables, Spo2 cables, Temp. Cables), Adapter cables, Adaptors,,Leg plate adaptors |
|---|---|
| Owner/operator | Orantech Inc. |
| Owner/operator number | 10058634 |
| Product codes | IKD |
| Device names | IKD - Cable, Electrode |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.1175 |
| Review panels | Physical Medicine |
| Registered establishments | ORANTECH INC. |
| Establishment registrations | 3013783488 |
| FEI numbers | 3013783488 |
| Establishment operations | Manufacturer |
| 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