FDA 510(k)

Infrared Body Thermometer

Número K: K180385 · 2018-05-11

Data da decisão2018-05-11

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2018-05-11 under 510(k) number K180385. 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 Body Thermometer?

Infrared Body Thermometer is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K180385.

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

Infrared Body Thermometer received FDA 510(k) clearance on 2018-05-11, under 510(k) number K180385.

Who is the listed applicant for 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 Infrared Body Thermometer?

The FDA product code for Infrared Body Thermometer is FLL.

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Outros registros que listam Hetaida Technology Co., Ltd. como candidato(a)

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

Ver todos os 8 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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