Replies to post #400952 on Innovation Pharmaceuticals Inc (IPIX)

[SitTight]

Substantial equivalence means that the new device is as safe and effective as the predicate.
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k#:~:text=Substantial%20equivalence%20means%20that%20the,and%20effective%20as%20the%20predicate.

[backtoreality]

That means the technology is equivalent to technology already approved by the F D Aaay!

Yay Leo. The man the myth the legend

Blast off count down beginning tomorrow. Any shares you can at these heavily manipulated prices will be Gold in your bank. Just wait for the reverse merger?, new ceo, stock goes through the roof and Leo walks away throwing a stick of dynamite on the bloody corrupt shorts

[sunspotter]

"Substantially Equivalent (SESE) —-to what?"

To the stuff that's allready out there. It means they can't make any claims to superiority.

Consider it the device equivalent of a generic drug, but in this case without any clinical studies to back up the claimed safety and efficacy, which is based purely on the physical similarity to an existing analog (the "predicate device").

https://openoximetry.org/faq/what-is-the-meaning-of-substantially-equivalent-for-fda-approval/