AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)— 510(k) K042642

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K042642 for AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR), Substantially Equivalent on 2004-11-03. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2004-09-27
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.