510(k) K982016

PIPER IPPB MODEL 2055 by Vortran Medical Technology 1, Inc. — Product Code NHJ

K982016 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "PIPER IPPB MODEL 2055". The FDA issued a decision of Substantially Equivalent on November 3, 1998. 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.