510(k) K172799

Positional Sleep Assessment System (PoSAS) software by Advanced Brain Monitoring — Product Code MNR

K172799 is an FDA 510(k) premarket notification submitted by Advanced Brain Monitoring for the device "Positional Sleep Assessment System (PoSAS) software". The FDA issued a decision of Substantially Equivalent on March 9, 2018. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Advanced Brain Monitoring has at least 10 other 510(k) clearances on record.