Fairmontmedical
AustraliaFDA applicant, unverified
- Devices
- 1
What Fairmontmedical makes
Fairmontmedical manufactures single-use protective covers for medical imaging and microscopy devices, including sealed camera covers, perforated camera covers, and microscope covers designed for various applications. Their product line also includes X-ray protective covers, which are intended to maintain sterility and reduce contamination during procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) registry, adhering to US medical device compliance standards.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fairmontmedical have in the registry?
The registry currently lists 1 device for Fairmontmedical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fairmontmedical's devices?
Among its 1 most recently registered device, Fairmontmedical has devices listed in FDA 510(k) (1 device).
What risk classes do Fairmontmedical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Fairmontmedical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fairmontmedical in the registry?
The most recently registered devices listed for Fairmontmedical include DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR.