Dolphys Medical B.V.
NetherlandsFDA 510(k) applicant, unverified
- Devices
- 1
What Dolphys Medical B.V. makes
Dolphys Medical B.V. manufactures the VENTRAIN, a medical device designed for cardiac monitoring and rhythm analysis, supporting real-time electrocardiogram (ECG) data acquisition and analysis.
The VENTRAIN is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Ventrain Ref K132759
510(k) 510(k)
Frequently asked questions
How many devices does Dolphys Medical B.V. have in the registry?
The registry currently lists 1 device for Dolphys Medical B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dolphys Medical B.V.'s devices?
Among its 1 most recently registered device, Dolphys Medical B.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Dolphys Medical B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dolphys Medical B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dolphys Medical B.V. in the registry?
The most recently registered devices listed for Dolphys Medical B.V. include VENTRAIN.