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Vaffan-Coulo

03/16/15 9:41 AM

#12690 RE: x1power #12688

"Who else had to do an ' elevated altitude study'..."???

See my previous post. It doesn't MATTER 'who," since the dario is being considered under a 510K application which does NOTHING more than COMPARE the device to ALREADY APPROVED devices.

Moreover, why do a clinical trial for an "altitude study"? That's nonsensical. That requires no more than ONE person going up in a plane and checking readings using control solutions.

It's nothing more than some stupid "penny stock" smoke and mirrors trick -- pap that brokers can use to lure in a few more suckers.