510(k) K052801— INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

Clearance details

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2005-10-03
Decision date: 2005-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Boeblingen, Baden-Wuerttemberg, DE

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.