510(k) K984431

ULTIMA AIRFLOW PRESSURE SENSOR by Braebon Medical Corp. — Product Code BZQ

K984431 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "ULTIMA AIRFLOW PRESSURE SENSOR". The FDA issued a decision of Substantially Equivalent on December 30, 1998. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Braebon Medical Corp. has at least 7 other 510(k) clearances on record.