510(k) K020700

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY by Pegasus Research Corp. — Product Code BTT

K020700 is an FDA 510(k) premarket notification submitted by Pegasus Research Corp. for the device "PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY". The FDA issued a decision of Substantially Equivalent on April 26, 2004. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Pegasus Research Corp. has at least 10 other 510(k) clearances on record.