510(k) K812041

VENTI-MONITOR MODEL 101 by Medix Medical Electronics (U.S.A.), Inc. — Product Code CAP

K812041 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "VENTI-MONITOR MODEL 101". The FDA issued a decision of Substantially Equivalent on September 25, 1981. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.