Tom Medical Entwicklungs GmbH
AustriaFDA applicant, unverified
- Devices
- 1
What Tom Medical Entwicklungs GmbH makes
Tom Medical Entwicklungs GmbH manufactures electrocardiogram (ECG) monitoring devices, including the MEDILOGAR4 and MEDILOGAR12 models, designed for continuous or ambulatory cardiac rhythm recording.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
MEDILOGAR4, MEDILOGAR12 Ref K070818
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tom Medical Entwicklungs GmbH have in the registry?
The registry currently lists 1 device for Tom Medical Entwicklungs GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tom Medical Entwicklungs GmbH's devices?
Among its 1 most recently registered device, Tom Medical Entwicklungs GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Tom Medical Entwicklungs GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tom Medical Entwicklungs GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tom Medical Entwicklungs GmbH in the registry?
The most recently registered devices listed for Tom Medical Entwicklungs GmbH include MEDILOGAR4, MEDILOGAR12.