510(k) K041952

ZIVF-AIRE by Zander Medical Supplies, Inc. — Product Code MQG

K041952 is an FDA 510(k) premarket notification submitted by Zander Medical Supplies, Inc. for the device "ZIVF-AIRE". The FDA issued a decision of Substantially Equivalent on September 8, 2005. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Zander Medical Supplies, Inc. has at least 4 other 510(k) clearances on record.