SUNRAY FETAL MONITOR— 510(k) K123335

Substantially Equivalent

Sunray Medical Apparatus Co., Ltd.

FDA 510(k) clearance K123335 for SUNRAY FETAL MONITOR, Substantially Equivalent on 2013-03-21. Applicant: Sunray Medical Apparatus Co., Ltd..

Clearance details

Applicant: Sunray Medical Apparatus Co., Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2012-10-26
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

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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.