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Are MAUDE Reports FRAUD Reports? Tag

What Happens if the FDA Revokes a 510K Should All Predicate Devices Follow?

June 3, 2014 The 510 (K), is a clearance the government gives to medical devices based off of substantially equivalent  or similar device (known as a  predicate device) already placed into one of the three classification categories.  To super simplify let's say a Crazy Straw was a new medical...