510(k) K020730

ORION NASAL CPAP SYSTEM by Bird Products Corp. — Product Code BZD

K020730 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "ORION NASAL CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 22, 2002. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Bird Products Corp. has at least 10 other 510(k) clearances on record.