FC 1400 FETAL MONITOR— 510(k) K043598

Name: FDA 510(k) clearance K043598
Creator: U.S. Food and Drug Administration
Published: 2005-12-16

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K043598 for FC 1400 FETAL MONITOR, Substantially Equivalent on 2005-12-16. Applicant: Bionet Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2004-12-29
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju, Kwangwon-Do, KR

Download summary PDF View on FDA.gov ↗

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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.