Product Classification

• Device: television or monitor, non-crt, non-medical, video display
• Definition: An electronic product designed to receive and display television or video signals from broadcast, cable, video player or recorder, computer, or other source. This may be a receiver or monitor or similar. This does not use a cathode ray tube (CRT) to display the image. This would include LED, OLED, LCD, Plasma technology televisions/monitors.
• Product Code: RIK
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible