510(k) K091572

DISPOSABLE SPO2 SENSOR M1134A by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code DQA

K091572 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "DISPOSABLE SPO2 SENSOR M1134A". The FDA issued a decision of Substantially Equivalent on September 22, 2009. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.