510(k) K962517

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV by Healthdyne Technologies, Inc. — Product Code MNS

K962517 is an FDA 510(k) premarket notification submitted by Healthdyne Technologies, Inc. for the device "MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Healthdyne Technologies, Inc. has at least 8 other 510(k) clearances on record.