FDA device listing
4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in.,4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in.,4…
FDA device listing 1825048834 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in.,4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in.,4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in.,4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in.,4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in.,4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in.,4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in.,4 Leadwire Expansion… |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Product codes | IKD |
| Device names | IKD - Cable, Electrode |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.1175 |
| Review panels | Physical Medicine |
| Registered establishments | Datex-Ohmeda, Inc., GE HEALTHCARE FINLAND OY, GE MEDICAL SYSTEMS (CHINA) CO., LTD., GE Medical Systems Information Technologies, Inc. |
| Establishment registrations | 9610105, 9710602, 3001570235, 3012359877, 3014220748, 3036470679 |
| FEI numbers | 3001570235, 3002806783, 3003513129, 3012359877, 3014220748, 3036470679 |
| Establishment operations | Manufacturer, Specification Developer |
| 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