New 510K VS Documents about design change.

HJCho

Registered
#1
Hi.

I'm RA person in medical device manufacturer.

I have question for voltage change.

My company has received the certificate of 510K(class2).
The documents and reports submitted at the time were 220V and received 510K for 220V.
If I change the this device's use voltage the 110V, Can I new 510K or just documents in company?
 
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primavesvera

Involved In Discussions
#2
If I were you, I'd consult their guidance Deciding When to Submit a 510(k) for a Change to an Existing Device and look for the diagram. Even if you decide to put this as a Letter to file, I'd insert the diagram and explain the rationale of my decision based on the diagram steps.
In the end, it boils down to how your modified device impacts the established safety and effectiveness of the previously cleared device.

I hope this helps, we used the diagram approach for a 510(k) Special and it worked like a charm.
 
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