INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90— 510(k) K082633
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K082633 for INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, Substantially Equivalent on 2008-10-03. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.
Clearance details
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Product code
- Code DSI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, Baden-Wuerttemberg, DE
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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.