Question: QUESTION 9 If two devices have the same end points and use the same technology, and have the same risks, would they be considered substantially

QUESTION 9 If two devices have the same end

QUESTION 9 If two devices have the same end points and use the same technology, and have the same risks, would they be considered substantially equivalent? Yes No QUESTION 10 What is the easiest way to determine what year a 510(k) was submitted? Find what day it was approved and subtract 90 days Call the FDA Look it up on the companies website Look at the first two numbers in the 510(k) number

Step by Step Solution

There are 3 Steps involved in it

1 Expert Approved Answer
Step: 1 Unlock blur-text-image
Question Has Been Solved by an Expert!

Get step-by-step solutions from verified subject matter experts

Step: 2 Unlock
Step: 3 Unlock

Students Have Also Explored These Related General Management Questions!