Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Advocate Non-Contact Infrared Thermometer

K-Number: K180355 · 2019-01-10

ApplicantBroadmaster Biotech, Corp.
Decision Date2019-01-10
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 2019-01-10 under approval number K180355. 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 2019-01-10. It is manufactured by Broadmaster Biotech, Corp.. The 510(k) number is K180355.

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

Advocate Non-Contact Infrared Thermometer received FDA 510(k) clearance on 2019-01-10, under approval number K180355.

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.

K191004Advocate 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.

↑