510(k) K002957

SOLAR SPO2 MODULE WITH MASIMO SET by General Electric Medical Systems Information Techn — Product Code DQA

K002957 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "SOLAR SPO2 MODULE WITH MASIMO SET". The FDA issued a decision of Substantially Equivalent on October 18, 2000. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.