Medelec, Ltd.
Country not established
- Devices
- 8
What Medelec, Ltd. makes
Medelec, Ltd. manufactures diagnostic and clinical neurophysiology systems, including the ARC, SAPPHIRE PREMIERE, TECA MILLENNIUM, DG 3P SYSTEM, DG EXAMINER PLUS, TECA PREMIERE, DG NERVUS, and DG PORTABLE SYSTEM.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) regulatory registry. The company is based in the United States.
Catalogue
Arc Ref K934669
Regimes: 510(k) Registry: 510(k)Sapphire Premiere Ref K923303
Regimes: 510(k) Registry: 510(k)Teca. Millennium Ref K965065
Regimes: 510(k) Registry: 510(k)Dg 3P System Ref K934670
Regimes: 510(k) Registry: 510(k)Dg Examiner Plus Ref K953799
Regimes: 510(k) Registry: 510(k)Teca Premiere Ref K953732
Regimes: 510(k) Registry: 510(k)Dg Nervus Ref K964280
Regimes: 510(k) Registry: 510(k)Dg Portable System Ref K954157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medelec, Ltd. have in the registry?
The registry currently lists 8 devices for Medelec, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medelec, Ltd.'s devices?
Among its 8 most recently registered devices, Medelec, Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Medelec, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Medelec, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medelec, Ltd. in the registry?
The most recently registered devices listed for Medelec, Ltd. include ARC, SAPPHIRE PREMIERE, TECA. MILLENNIUM and DG 3P SYSTEM.