Philips IntelliVue GuardianSoftware (Rev. E.0X)— 510(k) K212208

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K212208 for Philips IntelliVue GuardianSoftware (Rev. E.0X), Substantially Equivalent on 2021-09-30. Applicant: Philips Medizin Systeme Boeblingen GmbH.

Clearance details

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2021-07-15
Decision date: 2021-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boeblingen, 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.