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_Muthian2 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.