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Medical System with non-medical device and FCC

#1
Hey All, my team is designing a medical system consisting of medical device(will be certified to AAMI ES60601-1) and non-medical device ( will becertified to UL62368-1, no any wireless features) from sratch, which means we will also develop this medical devices and non-medical devices inside the system by ourselves. Now the regulatory question comes up and please correct me if I am wrong. My understanding is medical device/system is exempted from FCC requirement. In this case, how about the "non-medical device" in this medical system? should it comply with full FCC requirement? Your response will be high appreciated.
 
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