510(k) K173770

OJR215 Pressure Relief Manifold by Fisher & Paykel Healthcare Limited — Product Code CBP

K173770 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare Limited for the device "OJR215 Pressure Relief Manifold". The FDA issued a decision of Substantially Equivalent on April 5, 2019. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Fisher & Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.