510(k) K952491

MODEL 7355 by Devilbiss Health Care, Inc. — Product Code BZD

K952491 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "MODEL 7355". The FDA issued a decision of Substantially Equivalent on January 31, 1996. 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.