January, the World Health Organisation included use of pulse oximeter to identify patients who might need hospitalisation in its clinical advice for treating Covid-19.
But the FDA said the devices cannot be used to diagnose or rule out Covid-19, and generally it recommended not relying on them to assess health.
It recommended paying attention to other indicators of low oxygen, such as blueness of the face or a racing pulse.
The US health agency said the device might be "useful" for estimating blood oxygen levels, but multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use and use of fingernail polish.
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