Vitasystems GmbH
GermanyFDA 510(k) applicant, unverified
- Devices
- 3
What Vitasystems GmbH makes
Vitasystems GmbH makes the Vitaphone Model 100 BT, a Bluetooth-enabled device for cardiac monitoring, and the Vitaphone Tele ECG Loop Recorder, which records electrocardiogram data over time. They also produce EMMa Electronic Monitoring Management, a system for managing electronic monitoring data.
The devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Vitaphone. Model 100 Bt Ref K100383
510(k) 510(k)Vitaphone Tele ECG Loop Recorder Ref K151013
510(k) 510(k)EMMa Electronic Monitoring Management Ref K153477
510(k) 510(k)
Frequently asked questions
How many devices does Vitasystems GmbH have in the registry?
The registry currently lists 3 devices for Vitasystems GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vitasystems GmbH's devices?
Among its 3 most recently registered devices, Vitasystems GmbH has devices listed in FDA 510(k) (3 devices).
What risk classes do Vitasystems GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Vitasystems GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vitasystems GmbH in the registry?
The most recently registered devices listed for Vitasystems GmbH include VITAPHONE. MODEL 100 BT, Vitaphone Tele ECG Loop Recorder and EMMa Electronic Monitoring Management.