510(k) is approval from the (american) FDA. CE mark is a European certification - all of the machine (including the keyboard and power cable). The clarification by the company of the announcement was clear.
So yes, its not available in the USA until it has FDA approval. Whether CZM needs to wait for the FDA approval before commencing European sales I don't know.
510(k) is approval from the (american) FDA. CE mark is a...
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