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Article: Respironics Receives 510(k) Clearance from FDA for BiPAP(R) autoSV(TM) Device Designed for Complicated Sleep-Disordered Breathing Patients.
- Article from:
- PR Newswire
- Article date:
- March 7, 2007
CopyrightCOPYRIGHT 2007 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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MURRYSVILLE, Pa., March 7 /PRNewswire-FirstCall/ -- Respironics, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of the BiPAP autoSV device, which is intended to provide noninvasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
"We are excited about broadening our product portfolio in the sleep and respiratory markets with the BiPAP autoSV device, which expands our ability to provide life-changing therapy to a wider population of patients," said John L. Miclot, president and CEO of ...