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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 the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech, Corp.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) 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. The listed applicant is Broadmaster Biotech, Corp.. The 510(k) number is K191004.

When did Advocate Non-Contact Infrared Thermometer receive FDA 510(k) clearance?

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

Who is the listed applicant for Advocate Non-Contact Infrared Thermometer?

The FDA 510(k) record lists Broadmaster Biotech, Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Broadmaster Biotech, Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180355Advocate Non-Contact Infrared Thermometer

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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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