510(k) K952267

CRITERION, CRITERION I.V., MODIFIED by Nova-Ventrx — Product Code BZE

K952267 is an FDA 510(k) premarket notification submitted by Nova-Ventrx for the device "CRITERION, CRITERION I.V., MODIFIED". The FDA issued a decision of Substantially Equivalent on December 2, 1997. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Nova-Ventrx has at least 10 other 510(k) clearances on record.