510(k) K080348

OXISCAN II DATA MANAGEMENT SYSTEM by Airsep Corp. — Product Code DQA

K080348 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "OXISCAN II DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Airsep Corp. has at least 10 other 510(k) clearances on record.