510(k) K122996

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 by Xhale — Product Code DQA

K122996 is an FDA 510(k) premarket notification submitted by Xhale for the device "ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085". The FDA issued a decision of Substantially Equivalent on Apr 10, 2013. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Xhale has 2 other 510(k) clearances on record.