TERUMO FETAL MONITOR # FHM-602— 510(k) K801747

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K801747 for TERUMO FETAL MONITOR # FHM-602, Substantially Equivalent on 1980-08-13. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1980-07-28
Decision date: 1980-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.