510(k) K183111

Contour 24 by Quality Electrodynamics, LLC — Product Code MOS

K183111 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics, LLC for the device "Contour 24". The FDA issued a decision of Substantially Equivalent on December 7, 2018. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics, LLC has at least 10 other 510(k) clearances on record.