510(k) K212208

Philips IntelliVue GuardianSoftware (Rev. E.0X) by Philips Medizin Systeme Boeblingen GmbH — Product Code DXJ

K212208 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "Philips IntelliVue GuardianSoftware (Rev. E.0X)". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.