FDA 510(k)

Infrared Thermometer

Número K: K222248 · 2023-06-07

Data da decisão2023-06-07

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K222248. 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 Infrared Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Alicn Medical Shenzhen, Inc.. The 510(k) number is K222248.

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

Infrared Thermometer received FDA 510(k) clearance on 2023-06-07, under 510(k) number K222248.

Who is the listed applicant for Infrared Thermometer?

The FDA 510(k) record lists Alicn Medical Shenzhen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

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Outros registros que listam Alicn Medical Shenzhen, Inc. como candidato(a)

K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 K231050Arm Blood Pressure Monitor K230649Arm Blood Pressure Monitor K221913Arm Blood Pressure Monitor K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: FLL)

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.

Fonte oficial

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