Plantex USA, Inc.
Country not established
- Devices
- 1
What Plantex USA, Inc. makes
Plantex USA, Inc. manufactures the TPK 1980/1, a medical device designed for therapeutic or diagnostic use in a specific clinical context (device category not specified in data).
The TPK 1980/1 is classified as a Class II device under FDA regulations and is listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Tpk 1980/1 Ref K822449
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Plantex USA, Inc. have in the registry?
The registry currently lists 1 device for Plantex USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plantex USA, Inc.'s devices?
Among its 1 most recently registered device, Plantex USA, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Plantex USA, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Plantex USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plantex USA, Inc. in the registry?
The most recently registered devices listed for Plantex USA, Inc. include TPK 1980/1.