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The compatible Medical Cables, Inc. SpO2 Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO2 saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO2 Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.

SpO2 Finger Probe Models P856RA, P861RA, P862RA, P867RA, and P876RA

I cannot provide information about the acceptance criteria and study as the provided text is a 510(k) clearance letter for a medical device and does not contain the details of acceptance criteria or the study that proves the device meets those criteria. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to previously marketed devices.

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the performance data and the methods used to establish substantial equivalence.

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