510(k) K812046

TIDAL VOLUME MONITOR 150 by Medix Medical Electronics (U.S.A.), Inc. — Product Code BZK

K812046 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "TIDAL VOLUME MONITOR 150". The FDA issued a decision of Substantially Equivalent on August 7, 1981. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.