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This article was originally published in The Gray Sheet

Executive Summary

FDA approves the Puritan-Bennett Achieva portable volume ventilator. Suitable for children and adults, Achieva's "enhanced performance and pressure support capabilities bring Mallinckrodt full force into the subacute market," the firm says. The device also features "extended battery life," internal memory and modem for accessing stored data. Separately, Mallinckrodt's Nellcor N-395 pulse oximeter with Oxismart XL advanced signal processing and SatSeconds alarm management technology gains additional 510(k) clearance for use with Nellcor Oxisensor II adhesive sensors. The device was originally cleared in August to read through motion and deliver accurate oxygen saturation and pulse rate values using Nellcor adult and neonatal sensors. The expanded clearance extends the motion claim to include Nellcor pediatric and infant sensors

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