510(k) K871351

H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP by Holter-Hausner Intl. — Product Code BZD

K871351 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.