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teq0904

08/31/17 11:52 PM

#45666 RE: GreenOwner #45665

You have to do real world experiments on a running machine for a 510k application, so my guess is you can do other experiments with it too. Lots of unapproved devices are actually used for their intended purpose in the US under the guise of research purposes as I have mentioned before, so using it for an actual experiment seems to be allowable.