What is the classification of medical devices? What is the risk? Does it require a 510k or pre-market approval? Please explain and give an example of each.
a) Class I - Low risk - 510k required - Example: Bandages
b) Class II - Moderate risk - Pre-market approval required - Example: MRI machines
c) Class III - High risk - 510k required - Example: Tongue depressors
d) Class IV - Very high risk - Pre-market approval required - Example: Pacemakers