How to List a Medical Device

Y

yarina

#1
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.:thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
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.:thanx:
Clarification required! :confused:

Did company C buy devices A & B as ownership of their designs, or just some units?

The way you've described it, it sounds that the 510(k) submitted by company C is actually for a single device - B - and device A is just a component in / accessory for device B covered by the submission. If device A, as a stand-alone device (excluding device B extension) has a different intended use, I fail to understand how it could be covered by a single 510(k), unless some acceptable bundling rationale has been outlined.

Are companies A & B now making their A & B devices for company C as contract manufacturers? Are they located inside or outside the USA?

Cheers,
Ronen.
 
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