510(k) K072755

GALEMED CPAP MASK by Galemed Corp. — Product Code BZD

K072755 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "GALEMED CPAP MASK". The FDA issued a decision of Substantially Equivalent on November 16, 2007. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Galemed Corp. has at least 6 other 510(k) clearances on record.