510(k) K003684

PERCUSSIVENEB, MODEL PN-2001 by Vortran Medical Technology 1, Inc. — Product Code NHJ

K003684 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "PERCUSSIVENEB, MODEL PN-2001". The FDA issued a decision of Substantially Equivalent on February 23, 2001. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Vortran Medical Technology 1, Inc. has at least 10 other 510(k) clearances on record.