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Testing FDA cleared pulse oximeter

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Abishek Muthian

Abishek Muthian

Күн бұрын

Пікірлер: 2
@brianwest2775
@brianwest2775 2 жыл бұрын
It's actually FDA Cleared via a 510K Premarket Notification, not approved, which is for devices that go through a much more rigorous process called Premarket Approval (PMA). There is no such thing as FDA Certified. Being FDA Cleared is a good thing because then you know that the device did pass testing and should work as intended. (Strange because the box and device look like common fakes with a local company brand on the box and bogus quality certificate. But great that it works.) First time that I have seen someone try to progressively restrict the blood flow to their finger.
@Abishek_Muthian
@Abishek_Muthian 2 жыл бұрын
Thanks for the clarification, Should have researched more about what the 510K meant before publishing the content. But things were crazy then and I wanted more people to benefit from what it seems like good pulse-oximeter for a reasonable price. I've used it for over a year now and it does seem genuine and has been giving consistent results i.e. reduced SpO2 readings when infected with COVID. Replaced 'certified' with 'cleared' in the blog post.
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