510(k) K180534

Philips IntelliVue GuardianSoftware by Philips Medizin Systeme Boeblingen GmbH — Product Code DXJ

K180534 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "Philips IntelliVue GuardianSoftware". The FDA issued a decision of Substantially Equivalent on July 16, 2018. 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.