Search Results

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.

Ask a specific question about this device