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FDA 510(k)

Microlife Non-Contact Infrared Forehead Thermometer

K-Number: K191829 · 2020-02-13

ApplicantMicrolife Intellectual Property GmbH
Decision Date2020-02-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Microlife Non-Contact Infrared Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K191829. 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 Microlife Non-Contact Infrared Forehead Thermometer?

Microlife Non-Contact Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K191829.

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

Microlife Non-Contact Infrared Forehead Thermometer received FDA 510(k) clearance on 2020-02-13, under 510(k) number K191829.

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

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Microlife Intellectual Property GmbH 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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