510(k) K923117

CAVERNOSOMETRY MODULE FOR MENUET by Dantec Medical, Inc. — Product Code DXT

K923117 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "CAVERNOSOMETRY MODULE FOR MENUET". The FDA issued a decision of Substantially Equivalent on February 22, 1993. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.