(472 days)
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda, Novametrix 500, Novametrix Superbright, Spacelabs oximeter module, Criticare, BCI, Datascope.
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring.
This document is a 510(k) clearance letter from the FDA for a medical device (Epic Series E100 SpO2 Finger Sensor). It does not contain the detailed acceptance criteria and study information typically found in a device's design validation report or clinical study summary.
Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not elaborate on the specific performance metrics or the studies conducted to demonstrate those metrics.
§ 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).