Kuldeep Singh
Involved In Discussions
Hi Everyone,
We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind
1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.
We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind
1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.