Zargis Medical Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Zargis Medical Corp. makes
Zargis Medical Corp. manufactures acoustic cardiography devices, including the Zargis Acoustic Cardioscan (ZAC) and its variants (e.g., versions 6.28 and 9.33), as well as modifications to these systems. The portfolio also includes standalone diagnostic tools like the SIGNAL device, designed for cardiac monitoring and analysis.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Zargis Acoustic Cardioscan, Version 9.33 Ref K083309
510(k) 510(k)Signal Ref K090493
510(k) 510(k)Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 Ref K060197
510(k) 510(k)Zargis Acoustic Cardioscan Ref K031517
510(k) 510(k)Modification To Zargis Acoustic Cardioscan (Zac) Ref K042128
510(k) 510(k)
Frequently asked questions
How many devices does Zargis Medical Corp. have in the registry?
The registry currently lists 5 devices for Zargis Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zargis Medical Corp.'s devices?
Among its 5 most recently registered devices, Zargis Medical Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Zargis Medical Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Zargis Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zargis Medical Corp. in the registry?
The most recently registered devices listed for Zargis Medical Corp. include ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33, SIGNAL, ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 and ZARGIS ACOUSTIC CARDIOSCAN.