This article was originally published in The Gray Sheet
Receives notification from FDA that its N-400 fetal oximeter is not substantially equivalent and will require a premarket approval application. A 510(k) for the device was submitted in September 1992. Nellcor "has requested a meeting with FDA officials to obtain clarification on the agency's position, and to define the steps required to file a PMA," the firm says. The device is designed to measure the oxygen content in fetal blood during delivery via "a sensor that is noninvasive to the fetus".
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