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FDA 510(k)

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

K-Number: K202687 · 2021-02-18

ApplicantShenzhen Lepu Intelligent Medical Equipment Co., Ltd.
Decision Date2021-02-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202687. 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 Forehead Thermometer, Model LFR30B, LFR50, LFR60?

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K202687.

When did Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202687.

Who is the listed applicant for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60?

The FDA 510(k) record lists Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60?

The FDA product code for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is FLL.

Other records listing Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. as applicant

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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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