Data / Medical devices / Germany / Ezono AG
Ezono AG: FDA-registered device maker in Jena Thuringia, Germany, 1 510(k) clearance
Ezono AG is registered with the FDA (registration 3008515880) in Jena Thuringia, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008515880
- Address
- Spitzweidenweg 32, Jena Thuringia, Germany, D-07743
- Owner or operator
- eZono AG (10039166)
- Roles
- Exporter to the US
- First device listed
- November 17, 2022
- Registered through
- 2026
- Brand names listed
- SC1 Handheld Ultrasound Imaging System (Model: SC1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2021 | K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | IYO | Substantially Equivalent | Fcu Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated July 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.