K051175

Substantially Equivalent

CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION

Applicant: Civent Communications, Ltd.
Product code: HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2005-05-06
Decision date: 2006-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moshav Hemed, IL

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.