510(K) submission for clinical study devices

Thread starter mghaleb
Start date Jun 24, 2015

M

mghaleb

Jun 24, 2015

#1

Hi,

do i need a 510(K) Submission for clinical study purpose in USA?

thanks in advance.
Ghaleb

mihzago

Trusted Information Resource

Jun 24, 2015

#2

Re: 510(K) submission for clinical device

you need an Investigational Device Exemption (IDE)

M

mghaleb

Jun 25, 2015

#3

Re: 510(K) submission for clinical device

Thanks for your info.

You must log in or register to reply here.

Share:

Twitter Pinterest WhatsApp Email Link

This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.

Accept Learn more…