510(k) K071149

HRI 6500, 6600 AND 6700 SERIES V2MASKS by Hans Rudolph, Inc. — Product Code BZD

K071149 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "HRI 6500, 6600 AND 6700 SERIES V2MASKS". The FDA issued a decision of Substantially Equivalent on February 1, 2008. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.