INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90— 510(k) K083517
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K083517 for INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90, Substantially Equivalent on 2009-01-16. 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.