Respironics Georgia, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Respironics Georgia, Inc. makes
Respironics Georgia, Inc. manufactures medical software and monitoring devices, including the PROFOX software (model 920M-41) for respiratory care data management and the SMARTMONITOR 2 (model 4000) for patient monitoring in clinical settings.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance process. The company operates from the United States.
Catalogue
Profox Software, Model 920M-41 Ref K001708
Regimes: 510(k) Registry: 510(k)Smartmonitor 2, Model 4000 Ref K011597
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Respironics Georgia, Inc. have in the registry?
The registry currently lists 2 devices for Respironics Georgia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respironics Georgia, Inc.'s devices?
Among its 2 most recently registered devices, Respironics Georgia, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Respironics Georgia, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Respironics Georgia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Respironics Georgia, Inc. in the registry?
The most recently registered devices listed for Respironics Georgia, Inc. include PROFOX SOFTWARE, MODEL 920M-41 and SMARTMONITOR 2, MODEL 4000.