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Question 1 of 10
1. Question
How many classifications has FDA established for medical devices?
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Question 2 of 10
2. Question
Which classification of medical devices require Pre-Market Notification known as a 510(k)?
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Question 3 of 10
3. Question
Which classification is typical for a sleep apnea device?
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Question 4 of 10
4. Question
Does FDA’s Section 807.65 which exempts certain device establishments from what part of FDA compliance?
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Question 5 of 10
5. Question
How much time does FDA notify a domestic US establishment that FDA will perform an inspection?
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Question 6 of 10
6. Question
What is a 510(k)?
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Question 7 of 10
7. Question
What is a Predicate Device?
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Question 8 of 10
8. Question
Which of the following can trigger submission of a 510(k)?
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Question 9 of 10
9. Question
What is the date to qualify as a Pre-Amendment device?
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Question 10 of 10
10. Question
What is the fee for a business categorized as a Small Business by FDA to submit a 510(k)?
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