MODEL 116 FETAL MONITOR— 510(k) K891595

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K891595 for MODEL 116 FETAL MONITOR, Substantially Equivalent on 1989-06-12. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1989-03-20
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, 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.