510(k) K103802

TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR by GE Healthcare Finland Oy — Product Code DQA

K103802 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR". The FDA issued a decision of Substantially Equivalent on August 2, 2011. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.