510(k) K895360

C.P.A.P. VALVE AND C.P.P.A. KIT by Ballard Medical Products — Product Code BYE

K895360 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "C.P.A.P. VALVE AND C.P.P.A. KIT". The FDA issued a decision of Substantially Equivalent on November 15, 1989. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Ballard Medical Products has at least 10 other 510(k) clearances on record.