510(k) K911761

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION by S & W Medico Teknik — Product Code DQA

K911761 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 31, 1991. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. S & W Medico Teknik has at least 10 other 510(k) clearances on record.