510(k) K062091

POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION by Porous Media Corp. — Product Code BTT

K062091 is an FDA 510(k) premarket notification submitted by Porous Media Corp. for the device "POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION". The FDA issued a decision of Substantially Equivalent on August 8, 2006. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Porous Media Corp. has at least 8 other 510(k) clearances on record.