INTELLIVUE PATIENT MONITOR— 510(k) K093268

Substantially Equivalent

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

FDA 510(k) clearance K093268 for INTELLIVUE PATIENT MONITOR, Substantially Equivalent on 2010-05-11. 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: 2009-10-19
Decision date: 2010-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
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.