510(k) K050072

GOODKNIGHT 425ST by Nellcor Puritan Bennett, Inc. — Product Code BZD

K050072 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "GOODKNIGHT 425ST". The FDA issued a decision of Substantially Equivalent on June 13, 2005. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.