510(k) K915138

GE SONOCHROME by GE Medical Systems — Product Code MAA

K915138 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "GE SONOCHROME". The FDA issued a decision of Substantially Equivalent on October 20, 1992. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. GE Medical Systems has at least 10 other 510(k) clearances on record.