Zywie, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 3012164459
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
ZywieZ3 Sensor & Adhesive Ref K252839
510(k) 510(k)ZywieAI Software Library Ref K142693
510(k) 510(k)
Company details
- FDA FEI number
- 3012164459
- Address
- 12000 Findley Road, Johns Creek, GA, 30097
Frequently asked questions
How many devices does Zywie, Inc. have in the registry?
The registry currently lists 2 devices for Zywie, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zywie, Inc.'s devices?
Among its 2 most recently registered devices, Zywie, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Zywie, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Zywie, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zywie, Inc. in the registry?
The most recently registered devices listed for Zywie, Inc. include ZywieZ3 Sensor & Adhesive and ZywieAI Software Library.