K
kingkobra
We are developing a mobile app as an extension to an existing medical device. This application will use image / video from the medical device .
My Questions :-
1 ) what will be the class of the accessory ? in case of
a) Mobile application is controlling that existing medical device.
b) it is not controlling that existing medical device .
The existing device is classified in class 2 by FDA .
I'll be thankful if anyone can give me any supported doc or link for any such case.
Thanks in advance .
My Questions :-
1 ) what will be the class of the accessory ? in case of
a) Mobile application is controlling that existing medical device.
b) it is not controlling that existing medical device .
The existing device is classified in class 2 by FDA .
I'll be thankful if anyone can give me any supported doc or link for any such case.
Thanks in advance .
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