FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS— 510(k) K100797

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K100797 for FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS, Substantially Equivalent on 2010-11-10. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2010-03-22
Decision date: 2010-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.