TRAM MODULE— 510(k) K053121

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K053121 for TRAM MODULE, Substantially Equivalent on 2006-04-05. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2005-11-07
Decision date: 2006-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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.