Diacoustic Medical Devices (Pty), Ltd.
Country not established
- Devices
- 2
What Diacoustic Medical Devices (Pty), Ltd. makes
Diacoustic Medical Devices specializes in diagnostic applications for cardiac assessment, including mobile tools for detecting and analyzing heart murmurs. Their portfolio includes software-based solutions designed for point-of-care evaluation of cardiac conditions.
The company’s products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sensi Ref K110704
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diacoustic Medical Devices (Pty), Ltd. have in the registry?
The registry currently lists 2 devices for Diacoustic Medical Devices (Pty), Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diacoustic Medical Devices (Pty), Ltd.'s devices?
Among its 2 most recently registered devices, Diacoustic Medical Devices (Pty), Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Diacoustic Medical Devices (Pty), Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Diacoustic Medical Devices (Pty), Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diacoustic Medical Devices (Pty), Ltd. in the registry?
The most recently registered devices listed for Diacoustic Medical Devices (Pty), Ltd. include SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION and SENSI.