510(k) K002001

BREEZE SLEEPGEAR WITH DREAMSEAL by Puritan Bennett Corp. — Product Code BZD

K002001 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "BREEZE SLEEPGEAR WITH DREAMSEAL". The FDA issued a decision of Substantially Equivalent on September 6, 2000. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.