510(k) K833138

DIGITAL INJECTOR SYS by Sybron Corp. — Product Code DXT

K833138 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "DIGITAL INJECTOR SYS". The FDA issued a decision of Substantially Equivalent on November 14, 1983. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Sybron Corp. has at least 10 other 510(k) clearances on record.