510(k) K071230

APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 by Advanced Brain Monitoring, Inc. — Product Code MNR

K071230 is an FDA 510(k) premarket notification submitted by Advanced Brain Monitoring, Inc. for the device "APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Advanced Brain Monitoring, Inc. has at least 10 other 510(k) clearances on record.