Product Code: RBF FDA not classified

Video Monitor, Medical Imaging, Monochrome

Unknown

The Video Monitor, Medical Imaging, Monochrome (product code RBF) is an electronic product that uses a monochrome cathode ray tube to display medical images in black and white, shades of gray, or different shades of one color from signals generated by a computer or electronic medical device. This product is FDA not classified and is regulated under electronic product radiation control authority. It is GMP exempt with no associated regulation number, medical specialty, implant flag, or life-sustaining designation.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

Basic Information

Product Code
RBF
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.