510(k) K061874

INVACARE'S TWILIGHT II NASAL MASKS by Invacare Corp. — Product Code BZD

K061874 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "INVACARE'S TWILIGHT II NASAL MASKS". The FDA issued a decision of Substantially Equivalent on September 5, 2006. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Invacare Corp. has at least 10 other 510(k) clearances on record.