Data da decisão2020-10-07
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 Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200802. 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 2020-10-07. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K200802.
When did Infrared Thermometer receive FDA 510(k) clearance?
Infrared Thermometer received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200802.
Who is the listed applicant for Infrared Thermometer?
The FDA 510(k) record lists Shenzhen Urion Technology Co., Ltd. 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.
Ensaios clínicos relacionados
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Outros registros que listam Shenzhen Urion Technology Co., Ltd. como candidato(a)
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K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)K250046Massager de Perna de Compressão de Ar (UM605, UM606, UM607, UM608, UM609, UM610, UM611, UM617)K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)K160019U80 Series Upper Arm Electronic Blood Pressure Monitor Ver todos os 7 dispositivos →
Dispositivos Relacionados (Código: FLL)
Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.
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
Ver na base de dados da FDA →Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.