COROMETRICS MODEL 171 AND 172 FETAL MONITOR— 510(k) K991905

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K991905 for COROMETRICS MODEL 171 AND 172 FETAL MONITOR, Substantially Equivalent on 1999-09-01. Applicant: General Electric Medical Systems Information Techn.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1999-06-04
Decision date: 1999-09-01
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.