FETAL MONITORS— 510(k) K131941

Name: FDA 510(k) clearance K131941
Creator: U.S. Food and Drug Administration
Published: 2014-05-15

Substantially Equivalent

Guangdong Biolight Meditech Co., Ltd.

FDA 510(k) clearance K131941 for FETAL MONITORS, Substantially Equivalent on 2014-05-15. Applicant: Guangdong Biolight Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2013-06-27
Decision date: 2014-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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K153580 — Central Monitoring System2016-09-07

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.