510(k) K202733

Quantum Ventilation Module by Spectrum Medical , Ltd. — Product Code DTX

K202733 is an FDA 510(k) premarket notification submitted by Spectrum Medical , Ltd. for the device "Quantum Ventilation Module". The FDA issued a decision of Substantially Equivalent on October 16, 2020. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Spectrum Medical , Ltd. has at least 10 other 510(k) clearances on record.