510(k) K223217

Zynex Monitoring System, Model CM-1600 by Zynex Medical, Inc. — Product Code DSB

K223217 is an FDA 510(k) premarket notification submitted by Zynex Medical, Inc. for the device "Zynex Monitoring System, Model CM-1600". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Zynex Medical, Inc. has at least 4 other 510(k) clearances on record.