Burkhart Roentgen Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Burkhart Roentgen Intl., Inc. makes
Burkhart Roentgen Intl., Inc. manufactures radiographic protective equipment, including ORWO X-ray film for medical imaging and disposable protective radiographic gloves and eye shields designed to shield personnel from radiation exposure during X-ray procedures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Orwo X-Ray Film Ref K920539
Regimes: 510(k) Registry: 510(k)Protective Radiografic Glove Ref K920538
Regimes: 510(k) Registry: 510(k)Radiological Protective Eye Shield Ref K920540
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Burkhart Roentgen Intl., Inc. have in the registry?
The registry currently lists 3 devices for Burkhart Roentgen Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Burkhart Roentgen Intl., Inc.'s devices?
Among its 3 most recently registered devices, Burkhart Roentgen Intl., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Burkhart Roentgen Intl., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Burkhart Roentgen Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Burkhart Roentgen Intl., Inc. in the registry?
The most recently registered devices listed for Burkhart Roentgen Intl., Inc. include ORWO X-RAY FILM, PROTECTIVE RADIOGRAFIC GLOVE and RADIOLOGICAL PROTECTIVE EYE SHIELD.