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FDA 510(k)

Reusable Temperature Probe, Disposable Temperature Probe

K-Number: K223807 · 2023-08-25

ApplicantShenzhen Sino-K Medical Technology Co.,Ltd
Decision Date2023-08-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Reusable Temperature Probe, Disposable Temperature Probe is a medical device manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-25 under approval number K223807. 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 Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K223807.

When was Reusable Temperature Probe, Disposable Temperature Probe approved by the FDA?

Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance on 2023-08-25, under approval number K223807.

What company makes Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd.

What is the FDA product code for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA product code for Reusable Temperature Probe, Disposable Temperature Probe is FLL.

Related Clinical Trials

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Other Devices by Shenzhen Sino-K Medical Technology Co.,Ltd

K192608Disposable SpO2 Sensor K231961NIBPCuff

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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