510(k) K173793

XactTrace Single Use Respiratory Effort Belt System by Embla Systems — Product Code MNR

K173793 is an FDA 510(k) premarket notification submitted by Embla Systems for the device "XactTrace Single Use Respiratory Effort Belt System". The FDA issued a decision of Substantially Equivalent on March 1, 2019. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Embla Systems has at least 8 other 510(k) clearances on record.