510(k) K991212

MODIFICATION TO TRUZONE PEAK FLOW METER by Monaghan Medical Corp. — Product Code BZH

K991212 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "MODIFICATION TO TRUZONE PEAK FLOW METER". The FDA issued a decision of Substantially Equivalent on July 1, 1999. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.