510(k) K963415

VENTREX OXYGEN SENSOR by Ventrex, LLC — Product Code CCL

K963415 is an FDA 510(k) premarket notification submitted by Ventrex, LLC for the device "VENTREX OXYGEN SENSOR". The FDA issued a decision of Substantially Equivalent on November 25, 1996. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Ventrex, LLC has at least 5 other 510(k) clearances on record.