FDA-Cleared and FDA-Approved are two totally different things. Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.
If the device was FDA approved, the FDA has actually reviewed the product and not one similar to it.
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If the device was FDA approved, the FDA has actually reviewed the product and not one similar to it.
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