510(k) for Datex-Ohmeda's pulse oximeter:
This article was originally published in Clinica
Executive Summary
Datex-Ohmeda has received FDA 510(k) clearance to sell its 3900/3900P pulse oximeter with TeleOximetry remote fax capability. The company, of Liberty Corner, New Jersey, claims the device is the first to allow doctors to transmit up to 24 hours of oximetry data to a remote fax or computer. In addition, patient data can also be obtained via a personal computer from any location for analysis and diagnosis.