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FDA 510(k)

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

K-Number: K160308 · 2016-07-15

ApplicantFudakang Industrial Co., Ltd.
Decision Date2016-07-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is a medical device manufactured by Fudakang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under approval number K160308. 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 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Fudakang Industrial Co., Ltd.. The 510(k) number is K160308.

When was Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) approved by the FDA?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) received FDA 510(k) clearance on 2016-07-15, under approval number K160308.

What company makes Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is manufactured by Fudakang Industrial Co., Ltd..

What is the FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

The FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) 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 Fudakang Industrial Co., Ltd.

K172121Digital Thermometer

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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