FDA 510(k)

Non-contact infrared body thermometer

N.º K: K171888 · 2018-07-23

Fecha de decisión2018-07-23

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-contact infrared body thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K171888. 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 body thermometer?

Non-contact infrared body thermometer is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K171888.

When did Non-contact infrared body thermometer receive FDA 510(k) clearance?

Non-contact infrared body thermometer received FDA 510(k) clearance on 2018-07-23, under 510(k) number K171888.

Who is the listed applicant for Non-contact infrared body thermometer?

The FDA 510(k) record lists Hetaida Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact infrared body thermometer?

The FDA product code for Non-contact infrared body thermometer is FLL.

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Otros registros que enlistan a Hetaida Technology Co., Ltd. como solicitante

K243661Electronic Blood Pressure Monitor K241202Electric nasal aspirator (HTD2601US)K223170Electronic Blood Pressure Monitor, model: HTD6602US K203332Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C K200159Non-contact Infrared Body Thermometer, model:HTD8823US K180387Infrared Ear Thermometer

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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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