510(k) K103584

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS by Shenzhen Envisen Industry Co. Limited — Product Code DQA

K103584 is an FDA 510(k) premarket notification submitted by Shenzhen Envisen Industry Co. Limited for the device "ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on Jun 10, 2011. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.