FETAL MONITOR MODEL FHM-1— 510(k) K800013

Substantially Equivalent

Advantage Medical Systems, Inc.

FDA 510(k) clearance K800013 for FETAL MONITOR MODEL FHM-1, Substantially Equivalent on 1980-03-07. Applicant: Advantage Medical Systems, Inc..

Clearance details

Applicant: Advantage Medical Systems, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1980-01-04
Decision date: 1980-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.