Posted By
Ginger Cantor
15-May-2020 07:08
Found In
Egroup:
RAPS Twin Cities Chapter
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Hello Sourav This is an indications change (patient population) and would be a Traditional 510(k), in my opinion. For home use, if this device is medical electrical equipment, you will need to show you meet EMC limits for home use as defined in the 4th edition, and that you meet requirements of ...
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