510(k) K132696

TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR by GE Healthcare Finland Oy — Product Code DQA

K132696 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR". The FDA issued a decision of Substantially Equivalent on September 27, 2013. 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.