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FDA 510(k)

Infrared Forehead Thermometer

K-Number: K202420 · 2021-02-25

ApplicantConmo Electronic Company Limited
Decision Date2021-02-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Conmo Electronic Company Limited. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K202420. 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?

Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Conmo Electronic Company Limited. The 510(k) number is K202420.

When did Infrared Forehead Thermometer receive FDA 510(k) clearance?

Infrared Forehead Thermometer received FDA 510(k) clearance on 2021-02-25, under 510(k) number K202420.

Who is the listed applicant for Infrared Forehead Thermometer?

The FDA 510(k) record lists Conmo Electronic Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer is FLL.

Other records listing Conmo Electronic Company Limited 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.

K202372Upper Arm Electronic Blood Pressure Monitor

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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