510(k) K946077

DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS by Hans Rudolph, Inc. — Product Code BZC

K946077 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.