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Dear all,
I have a confusion on the medical device listing, any expert help me to anlysis it?
Company A has manufactured a medical device named "A", which can complete the intended function itself.
Company B has manufactured a medical device named "B", wihch can receive measurement value from device "A", and can only complete its intended function with device"A".
Company C bought medical device "A" and "B" from comany A and company B, and applied a 510(K) for device "A" and "B".
Device "A" and "B" has the same 510(K) number, how can comany A and company B list and distinguish their own device with the same 510(K) number?
Thanks all.
I have a confusion on the medical device listing, any expert help me to anlysis it?
Company A has manufactured a medical device named "A", which can complete the intended function itself.
Company B has manufactured a medical device named "B", wihch can receive measurement value from device "A", and can only complete its intended function with device"A".
Company C bought medical device "A" and "B" from comany A and company B, and applied a 510(K) for device "A" and "B".
Device "A" and "B" has the same 510(K) number, how can comany A and company B list and distinguish their own device with the same 510(K) number?
Thanks all.
