510(k) K895031

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

K895031 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "MODIFIED INFANT NASAL CANNULAE ASSEMBLY". The FDA issued a decision of Substantially Equivalent on October 30, 1989. 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.