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IT Dr. Gambert's reusable medical SpO2 sensors, the FS and PS "silc touch" Series and FC, FP and Y Series, are intended to non-invasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with the BCI Advisor, Datex Ohmeda TuffSat, HP Philips M3, Nellcor NPB-40 and Novametrix 512 pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.

IT Dr. Gambert's reusable SpO2 sensors are produced in several configurations as after market replacements for use with a wide variety of commercially available pulse oximeters. They are substantially equivalent (identical) to the listed predicate devices and all other SpO2 sensors currently cleared for marketing in the United States.