INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550— 510(k) K131872

Substantially Equivalent

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

FDA 510(k) clearance K131872 for INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550, Substantially Equivalent on 2013-10-17. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.

Clearance details

Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2013-06-24
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Boeblingen, Baden-Wuerttemberg, DE

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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.