510(k) K051559

IMASK, MODELS 100, 200 AND 300 by Vital Signs Colorado, Inc. — Product Code BZD

K051559 is an FDA 510(k) premarket notification submitted by Vital Signs Colorado, Inc. for the device "IMASK, MODELS 100, 200 AND 300". The FDA issued a decision of Substantially Equivalent on July 8, 2005. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.