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FDA 510(k)

Disposable Temperature Probe

K-Number: K182755 · 2018-12-21

ApplicantShenzhen Caremed Medical Technology Co., Ltd.
Decision Date2018-12-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Temperature Probe is a medical device manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under approval number K182755. 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 Disposable Temperature Probe?

Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K182755.

When was Disposable Temperature Probe approved by the FDA?

Disposable Temperature Probe received FDA 510(k) clearance on 2018-12-21, under approval number K182755.

What company makes Disposable Temperature Probe?

Disposable Temperature Probe is manufactured by Shenzhen Caremed Medical Technology Co., Ltd..

What is the FDA product code for Disposable Temperature Probe?

The FDA product code for Disposable Temperature Probe is FLL.

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Other Devices by Shenzhen Caremed Medical Technology Co., Ltd.

K153188Caremed patient cable and leadwires K153184Caremed Reusable & Disposable SPO2 Sensors K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K191279Disposable SpO2 Sensor K182751Reusable Temperature Probe

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

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

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