Rosys, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Rosys, Inc. makes
Rosys, Inc. manufactures the PLATO 3000 and PLATO 3300/1300, which appear to be medical devices designed for patient monitoring or therapeutic applications, likely within critical care or respiratory support settings.
These devices fall under Class I regulation in the US and are listed via FDA 510(k) clearance. The company is based in the United States.
Catalogue
Plato 3000 Ref K933088
Regimes: 510(k) Registry: 510(k)Plato 3300/1300 Ref K943454
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rosys, Inc. have in the registry?
The registry currently lists 2 devices for Rosys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rosys, Inc.'s devices?
Among its 2 most recently registered devices, Rosys, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Rosys, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rosys, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rosys, Inc. in the registry?
The most recently registered devices listed for Rosys, Inc. include PLATO 3000 and PLATO 3300/1300.