Rotem Industries C/O Medsys, Inc.
Country not established
- Devices
- 1
What Rotem Industries C/O Medsys, Inc. makes
Rotem Industries, through Medsys, Inc., manufactures the Model 10200 Premature Infant Incubator, a medical device designed to provide controlled thermal and environmental support for premature or low-birth-weight infants.
The Model 10200 Premature Infant Incubator is classified as a Class II device under FDA regulations and is listed via a 510(k) clearance. The company is based in the United States.
Catalogue
Model 10200 Premature Infant Incubator Ref K862921
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rotem Industries C/O Medsys, Inc. have in the registry?
The registry currently lists 1 device for Rotem Industries C/O Medsys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rotem Industries C/O Medsys, Inc.'s devices?
Among its 1 most recently registered device, Rotem Industries C/O Medsys, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rotem Industries C/O Medsys, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rotem Industries C/O Medsys, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rotem Industries C/O Medsys, Inc. in the registry?
The most recently registered devices listed for Rotem Industries C/O Medsys, Inc. include MODEL 10200 PREMATURE INFANT INCUBATOR.