510k is just a notification isnt it?its not some long winded...

510k is just a notification isnt it?

its not some long winded approval process that medical devices go through

i have read bits and pieces that support what you are saying, but a comms device receiving clinical information doesnt sound like it would require extensive regulatory approval and cost a fortune and take forever for approval

it just doesnt make sense

i have done regulatory testing for electronic medical records and it was quick to set up and to retest cost $10k. But that is Australia, but I cant see why it would be too different in the US