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FDA 510(k)

Digital Thermometer, Model T28, T28L

K-Number: K232678 · 2024-01-31

ApplicantGuangdong Genial Technology Co., Ltd.
Decision Date2024-01-31
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer, Model T28, T28L is a medical device manufactured by Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under approval number K232678. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Thermometer, Model T28, T28L?

Digital Thermometer, Model T28, T28L is a medical device that received FDA 510(k) clearance on 2024-01-31. It is manufactured by Guangdong Genial Technology Co., Ltd.. The 510(k) number is K232678.

When was Digital Thermometer, Model T28, T28L approved by the FDA?

Digital Thermometer, Model T28, T28L received FDA 510(k) clearance on 2024-01-31, under approval number K232678.

What company makes Digital Thermometer, Model T28, T28L?

Digital Thermometer, Model T28, T28L is manufactured by Guangdong Genial Technology Co., Ltd..

What is the FDA product code for Digital Thermometer, Model T28, T28L?

The FDA product code for Digital Thermometer, Model T28, T28L is FLL.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41346994 The status quo of the development of decentralized clinical trials. Frontiers in medicine (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Guangdong Genial Technology Co., Ltd.

K231250Digital Blood Pressure Monitor K231245Digital Blood Pressure Monitor (Arm Type) K231243Finger Clip Pulse Oximeter K240333Wearable Digital Thermometer (T31)

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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