510(k) K911780

INFANT NASAL CANNULAE ASSEMBLY, MODIFIED by Ackrad Laboratories — Product Code BZD

K911780 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "INFANT NASAL CANNULAE ASSEMBLY, MODIFIED". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Ackrad Laboratories has at least 10 other 510(k) clearances on record.