(167 days)
The Beddr 200 System is a reusable forehead reflectance sensor indicated for use in measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spotchecking and/or data collection and recording of patients during no motion conditions, who are well perfused, in a home or healthcare environment.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The text is an FDA 510(k) clearance letter for the Beddr 200 System, outlining the device's indications for use and general regulatory information. It does not include specific performance criteria, study design, sample sizes, expert qualifications, or ground truth methodologies that you have requested.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).