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FDA 510(k)

Non-contact Electronic Forehead Infrared Thermometer

K-Number: K201582 · 2021-01-15

ApplicantZhongshan Jinli Electronic Weighing  Equipment Co., Ltd.
Decision Date2021-01-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Electronic Forehead Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Jinli Electronic Weighing  Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201582. 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 Non-contact Electronic Forehead Infrared Thermometer?

Non-contact Electronic Forehead Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Zhongshan Jinli Electronic Weighing  Equipment Co., Ltd.. The 510(k) number is K201582.

When did Non-contact Electronic Forehead Infrared Thermometer receive FDA 510(k) clearance?

Non-contact Electronic Forehead Infrared Thermometer received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201582.

Who is the listed applicant for Non-contact Electronic Forehead Infrared Thermometer?

The FDA 510(k) record lists Zhongshan Jinli Electronic Weighing  Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Electronic Forehead Infrared Thermometer?

The FDA product code for Non-contact Electronic Forehead Infrared Thermometer is FLL.

Related Clinical Trials

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Other records listing Zhongshan Jinli Electronic Weighing  Equipment Co., Ltd. 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.

K231116Multi-parameter detector

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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