FDA 510(k)

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)

Número K: K211776 · 2022-03-01

RequerenteMicrolife Intellectual Property GmbH

Data da decisão2022-03-01

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) 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 2022-03-01 under 510(k) number K211776. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211776.

When did Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) receive FDA 510(k) clearance?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) received FDA 510(k) clearance on 2022-03-01, under 510(k) number K211776.

Who is the listed applicant for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

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, Model FR1MF1-B (NC150 BT)?

The FDA product code for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is FLL.

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