510(k) K893476

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. by Andros Analyzers, Inc. — Product Code JAA

K893476 is an FDA 510(k) premarket notification submitted by Andros Analyzers, Inc. for the device "ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.". The FDA issued a decision of Substantially Equivalent on Jun 23, 1989. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Andros Analyzers, Inc. has 4 other 510(k) clearances on record.