510(k) K982216

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 by Braebon Medical Corp. — Product Code BZQ

K982216 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522". The FDA issued a decision of Substantially Equivalent on September 11, 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.