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FDA 510(k)

Infrared Thermometer, model: PC808

K-Number: K190717 · 2019-12-13

ApplicantShenzhen Pacom Medical Instruments Co., Ltd.
Decision Date2019-12-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer, model: PC808 is a medical device manufactured by Shenzhen Pacom Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under approval number K190717. 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 Infrared Thermometer, model: PC808?

Infrared Thermometer, model: PC808 is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Shenzhen Pacom Medical Instruments Co., Ltd.. The 510(k) number is K190717.

When was Infrared Thermometer, model: PC808 approved by the FDA?

Infrared Thermometer, model: PC808 received FDA 510(k) clearance on 2019-12-13, under approval number K190717.

What company makes Infrared Thermometer, model: PC808?

Infrared Thermometer, model: PC808 is manufactured by Shenzhen Pacom Medical Instruments Co., Ltd..

What is the FDA product code for Infrared Thermometer, model: PC808?

The FDA product code for Infrared Thermometer, model: PC808 is FLL.

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Other Devices by Shenzhen Pacom Medical Instruments Co., Ltd.

K172889Infrared 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

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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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