FDA 510(k)

Non-contact Infrared Thermometer

N.º K: K180207 · 2018-11-28

SolicitanteAlicn Medical (Shenzhen), Inc.

Fecha de decisión2018-11-28

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-contact 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 2018-11-28 under 510(k) number K180207. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Non-contact Infrared Thermometer?

Non-contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is Alicn Medical (Shenzhen), Inc.. The 510(k) number is K180207.

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

Non-contact Infrared Thermometer received FDA 510(k) clearance on 2018-11-28, under 510(k) number K180207.

Who is the listed applicant for Non-contact 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 Non-contact Infrared Thermometer?

The FDA product code for Non-contact Infrared Thermometer is FLL.

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Otros registros que enlistan a Alicn Medical (Shenzhen), Inc. como solicitante

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 K231050Monitor de Presión Arterial de Brazo K230649Monitor de Presión Arterial de Brazo K222248Infrared Thermometer K221913Monitor de Presión Arterial de Brazo K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

Ver todos los 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.

Fuente oficial

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