MINDCHILD MERIDIAN FETAL HEART RATE MONITOR— 510(k) K120018

Substantially Equivalent

Mindchild Medical

FDA 510(k) clearance K120018 for MINDCHILD MERIDIAN FETAL HEART RATE MONITOR, Substantially Equivalent on 2012-09-19. Applicant: Mindchild Medical.

Clearance details

Applicant: Mindchild Medical
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2012-01-03
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

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.