THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS— 510(k) K062283

Substantially Equivalent

Philips Medical Systems North America, Inc.

FDA 510(k) clearance K062283 for THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS, Substantially Equivalent on 2006-09-20. Applicant: Philips Medical Systems North America, Inc..

Clearance details

Applicant: Philips Medical Systems North America, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2006-08-07
Decision date: 2006-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Boeblingen, 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.