Diagnostic Devices Pty, Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
What Diagnostic Devices Pty, Ltd. makes
Diagnostic Devices Pty, Ltd. manufactures the HEARTEVENT (Model AT), a cardiac monitoring device designed for detecting and recording heart rhythm abnormalities.
The HEARTEVENT (Model AT) is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Heartevent, Model At Ref K072385
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnostic Devices Pty, Ltd. have in the registry?
The registry currently lists 1 device for Diagnostic Devices Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostic Devices Pty, Ltd.'s devices?
Among its 1 most recently registered device, Diagnostic Devices Pty, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Diagnostic Devices Pty, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Diagnostic Devices Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostic Devices Pty, Ltd. in the registry?
The most recently registered devices listed for Diagnostic Devices Pty, Ltd. include HEARTEVENT, MODEL AT.