Medical Device Manufacturer · US , Pinellas Park , FL

Burkhart Roentgen Intl., Inc.

3 submissions · 3 cleared · Since 1992
3
Total
3
Cleared
0
Denied

Burkhart Roentgen Intl., Inc. — FDA 510(k) Submissions

Burkhart Roentgen Intl., Inc. has submitted 3 FDA 510(k) premarket notifications since 1992, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radiographic Protective Glove, Film, Radiographic, Shield, Eye, Radiological . Use the specialty filter in the sidebar to narrow results.

3 devices
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All3 Radiology 3