510(k) K220107

Mindray SV600 Ventilator, Mindray SV800 Ventilator by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code CBK

K220107 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "Mindray SV600 Ventilator, Mindray SV800 Ventilator". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.