Product Code: RDY FDA not classified

Metal Halide Lamp

Unknown

The Metal Halide Lamp (product code RDY) is a high-intensity mercury vapor discharge lamp, including mercury vapor or metal halide lamps (excluding tungsten filament self-ballasted mercury vapor lamps), incorporating a high pressure arc discharge tube with a fill consisting of mercury contained within an outer envelope. 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
RDY
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

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

Definition

High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a fill consisting of mercury and that is contained within an outer envelope.