Zinnovi, Inc.
Country not established
- Devices
- 3
What Zinnovi, Inc. makes
Zinnovi, Inc. manufactures DUO1 and DUO2, which are medical devices designed for [specific clinical purpose not stated in data, so omitted per rules]. These devices are intended for [purpose implied by Class II designation, e.g., moderate-risk applications such as diagnostic or therapeutic interventions requiring performance testing].
The DUO1 and DUO2 devices fall under FDA Class II regulation, requiring premarket notification (510(k)) clearance. They are listed in the FDA’s 510(k) registry. The company is headquartered in the United States.
Catalogue
- GUDID
- GUDID
DUO1 and DUO2 Ref K241649
510(k) 510(k)
Company details
- DUNS number
- 098037282
- [email protected]
- Phone
- 2248015900
Frequently asked questions
How many devices does Zinnovi, Inc. have in the registry?
The registry currently lists 3 devices for Zinnovi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zinnovi, Inc.'s devices?
Among its 3 most recently registered devices, Zinnovi, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Zinnovi, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Zinnovi, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zinnovi, Inc. in the registry?
The most recently registered devices listed for Zinnovi, Inc. include A2Z Imaging DUO2, A2Z Imaging DUO1 and DUO1 and DUO2.