M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II— 510(k) K040357

Substantially Equivalent

Philips Medical Systems, Inc.

FDA 510(k) clearance K040357 for M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II, Substantially Equivalent on 2004-03-03. Applicant: Philips Medical Systems, Inc..

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2004-02-13
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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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.