INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216— 510(k) K111905

Substantially Equivalent

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

FDA 510(k) clearance K111905 for INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, Substantially Equivalent on 2011-10-04. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.

Clearance details

Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2011-07-05
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boeblingen, Baden-Wuerttemberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.