510(k) K233656

Contour Shoulder by Quality Electrodynamics — Product Code MOS

K233656 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics for the device "Contour Shoulder". The FDA issued a decision of Substantially Equivalent on February 15, 2024. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics has at least 10 other 510(k) clearances on record.