510(k) K030515

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS by Hans Rudolph, Inc. — Product Code CBK

K030515 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS". The FDA issued a decision of Substantially Equivalent on May 2, 2003. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.