MONITOR, OFFICE MODEL 140— 510(k) K790139

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K790139 for MONITOR, OFFICE MODEL 140, Substantially Equivalent on 1979-02-16. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1979-01-19
Decision date: 1979-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.