Hello Silu,
Yes, should be ok as others indicated make sure it conforms to current FDA requirements. The electrical disturbance standard is an international standard and some countries have specific requirements, so make sure the United States requirements are being met with the testing report you have available. If you are unsure, you should be able to ask the testing laboratory for any deviations by country.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-May-2023 09:08
From: Silu Zhang
Subject: 510(k)
ok Great,
Thanks for the info!
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Silu Zhang
West Vancouver BC
Canada
Original Message:
Sent: 26-May-2023 01:57
From: Anonymous Member
Subject: 510(k)
This message was posted by a user wishing to remain anonymous
Dear Zhang,
be aware that the FDA has a new Guidance on EMC Requirements. Please check internal if 5G and frequences are part of the Reports.
Kind regards
Anonymous
Original Message:
Sent: 25-May-2023 07:04
From: Silu Zhang
Subject: 510(k)
I have a question regarding EMC.
I want to submit a new tradtional 510(k) and we had the EMC report and documents back in 2019.
My question is should we do a new test regarding this new submiision? or we could just use the old report.
Thanks.
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Silu Zhang
West Vancouver BC
Canada
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