CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION— 510(k) K051175

Substantially Equivalent

Civent Communications, Ltd.

FDA 510(k) clearance K051175 for CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION, Substantially Equivalent on 2006-02-17. Applicant: Civent Communications, Ltd..

Clearance details

Applicant: Civent Communications, Ltd.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.