510(k) K832793

NEOCATH 1000 W/HEPCOTE by Orange Medical Instruments, Inc. — Product Code CCE

K832793 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "NEOCATH 1000 W/HEPCOTE". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.