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FDA 510(k)

Medical electronic thermometer (FC01, FC02)

K-Number: K240109 · 2024-04-12

ApplicantZhuzhou Goldenhot Medical Technology Co., Ltd.
Decision Date2024-04-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical electronic thermometer (FC01, FC02) is a medical device manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under approval number K240109. 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 Medical electronic thermometer (FC01, FC02)?

Medical electronic thermometer (FC01, FC02) is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K240109.

When was Medical electronic thermometer (FC01, FC02) approved by the FDA?

Medical electronic thermometer (FC01, FC02) received FDA 510(k) clearance on 2024-04-12, under approval number K240109.

What company makes Medical electronic thermometer (FC01, FC02)?

Medical electronic thermometer (FC01, FC02) is manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd..

What is the FDA product code for Medical electronic thermometer (FC01, FC02)?

The FDA product code for Medical electronic thermometer (FC01, FC02) is FLL.

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Related PubMed Literature

PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 41378019 Advancing circular economy practices in radiography: a narrative review of sustainable medical imaging. Translational cancer research (2025)

Other Devices by Zhuzhou Goldenhot Medical Technology Co., Ltd.

K231613Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)

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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