510(k) K935979

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM by Devilbiss Health Care, Inc. — Product Code BZD

K935979 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.