510(k) K030822

7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS by Hans Rudolph, Inc. — Product Code BZD

K030822 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS". The FDA issued a decision of Substantially Equivalent on June 3, 2003. 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.