$7.24
Multiple Function: Monitors Pulse and Blood Oxygen Saturation Rate. Infrared detection, quick result in 8 seconds. Easy to Use: Turn on the oximeter by...
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Mar 23, 2018 · FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters.
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A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, ...
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This oximeter is a versatile tool that can measure both pulse and blood oxygen saturation rate. Utilizing infrared detection, it provides quick results in ...
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Nov 16, 2023 · A pulse oximeter is a device that is usually placed on a fingertip that uses light beams to estimate the oxygen saturation of the blood and ...
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Nov 1, 2022 · ... pulse oximeter accuracy, the FDA performed an initial examination of prior cleared 510(k) submissions under product code DQA to better.
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