510(k) K192860

Sapphire Infusion Pump, Sapphire administration sets by Q Core Medical , Ltd. — Product Code FRN

K192860 is an FDA 510(k) premarket notification submitted by Q Core Medical , Ltd. for the device "Sapphire Infusion Pump, Sapphire administration sets". The FDA issued a decision of Substantially Equivalent on Nov 19, 2020. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Q Core Medical , Ltd. has 4 other 510(k) clearances on record.