510(k) K143031

mcompass Biofeedback Anorectal Manometry System by Medspira, LLC — Product Code KLA

K143031 is an FDA 510(k) premarket notification submitted by Medspira, LLC for the device "mcompass Biofeedback Anorectal Manometry System". The FDA issued a decision of Substantially Equivalent on July 7, 2015. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Medspira, LLC has at least 2 other 510(k) clearances on record.