FDA 510(k)

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

N.º K: K161933 · 2016-08-16

SolicitanteKaz USA, Inc., A Helen of Troy Company

Fecha de decisión2016-08-16

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

The Braun ThermoScan® 3 High Speed Compact Ear 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 2016-08-16 under 510(k) number K161933. 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K161933.

When did The Braun ThermoScan® 3 High Speed Compact Ear Thermometer receive FDA 510(k) clearance?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161933.

Who is the listed applicant for The Braun ThermoScan® 3 High Speed Compact Ear 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear 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

Ver todos los 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.

Fuente oficial

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