Digital Thermometer, Model T28, T28L— 510(k) K232678

Substantially Equivalent

Guangdong Genial Technology Co., Ltd.

FDA 510(k) clearance K232678 for Digital Thermometer, Model T28, T28L, Substantially Equivalent on 2024-01-31. Applicant: Guangdong Genial Technology Co., Ltd..

Clearance details

Applicant: Guangdong Genial Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2023-09-01
Decision date: 2024-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhaoqing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.