510(k) K960203

G.E. STERILE AMNIOCENTESIS TRAY by GE Medical Systems — Product Code HIO

K960203 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "G.E. STERILE AMNIOCENTESIS TRAY". The FDA issued a decision of Substantially Equivalent on March 14, 1996. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. GE Medical Systems has at least 10 other 510(k) clearances on record.