Philips IntelliVue GuardianSoftware— 510(k) K151736
Substantially EquivalentPhilips Medizin Systeme Boblingen GmbH
FDA 510(k) clearance K151736 for Philips IntelliVue GuardianSoftware, Substantially Equivalent on 2015-10-21. Applicant: Philips Medizin Systeme Boblingen GmbH.
Clearance details
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Product code
- Code DXJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boblingen, DE
Adverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.