what I don't understand is why the FDA is taking so long for over the counter approval of the PRIZMA. from my understanding this should be a standard class II submission as exisiting products exist with similar tech, yet they give apple thumbs up for a piece of sh*t device that isn't for people with pre-existing heart conditions - the main point of an ekg for most, correct me if I'm wrong. I don't have a heart or beat condition, not sure why I would need ekg...
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Ann: CE, FDA and CFDA Approval - Guangzhou Production Facility, page-475
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