510(k) K974879

MODEL 7410 VOYAGER by Healthdyne Technologies, Inc. — Product Code BZD

K974879 is an FDA 510(k) premarket notification submitted by Healthdyne Technologies, Inc. for the device "MODEL 7410 VOYAGER". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Healthdyne Technologies, Inc. has at least 8 other 510(k) clearances on record.