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FDA 510(k)

Advocate Non-Contact Infrared Thermometer

K-Number: K191004 · 2019-09-05

ApplicantBroadmaster Biotech, Corp.
Decision Date2019-09-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Advocate Non-Contact Infrared Thermometer is a medical device manufactured by Broadmaster Biotech, Corp.. It received FDA 510(k) clearance on 2019-09-05 under approval number K191004. 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 Advocate Non-Contact Infrared Thermometer?

Advocate Non-Contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Broadmaster Biotech, Corp.. The 510(k) number is K191004.

When was Advocate Non-Contact Infrared Thermometer approved by the FDA?

Advocate Non-Contact Infrared Thermometer received FDA 510(k) clearance on 2019-09-05, under approval number K191004.

What company makes Advocate Non-Contact Infrared Thermometer?

Advocate Non-Contact Infrared Thermometer is manufactured by Broadmaster Biotech, Corp..

What is the FDA product code for Advocate Non-Contact Infrared Thermometer?

The FDA product code for Advocate Non-Contact Infrared Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Broadmaster Biotech, Corp.

K180355Advocate Non-Contact Infrared 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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