FDA 510(k)

VDT985US Vicks SmartTemp Thermometer

N.º K: K152975 · 2016-03-23

SolicitanteKaz USA, Inc., A Helen of Troy Company

Fecha de decisión2016-03-23

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

VDT985US Vicks SmartTemp Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152975. 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 VDT985US Vicks SmartTemp Thermometer?

VDT985US Vicks SmartTemp Thermometer is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K152975.

When did VDT985US Vicks SmartTemp Thermometer receive FDA 510(k) clearance?

VDT985US Vicks SmartTemp Thermometer received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152975.

Who is the listed applicant for VDT985US Vicks SmartTemp Thermometer?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VDT985US Vicks SmartTemp Thermometer?

The FDA product code for VDT985US Vicks SmartTemp Thermometer is FLL.

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Otros registros que enlistan a Kaz USA, Inc., A Helen of Troy Company como solicitante

K212609BHA100 Series Braun Clear Hearing Aid K193213Vicks VNT200 No Touch Forehead Thermometer K180131Vicks RapidRead Digital Thermometer K181242Braun BNT400 No Touch + Forehead Thermometer K181015Braun BFH175 Infrared Forehead Thermometer K163516Braun No Touch + Forehead NTF3000 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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