FDA 510(k)

Braun BFH175 Infrared Forehead Thermometer

N.º K: K181015 · 2018-07-18

SolicitanteKaz USA, Inc., A Helen of Troy Company

Fecha de decisión2018-07-18

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Braun BFH175 Infrared Forehead 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 2018-07-18 under 510(k) number K181015. 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 Braun BFH175 Infrared Forehead Thermometer?

Braun BFH175 Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K181015.

When did Braun BFH175 Infrared Forehead Thermometer receive FDA 510(k) clearance?

Braun BFH175 Infrared Forehead Thermometer received FDA 510(k) clearance on 2018-07-18, under 510(k) number K181015.

Who is the listed applicant for Braun BFH175 Infrared Forehead 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 Braun BFH175 Infrared Forehead Thermometer?

The FDA product code for Braun BFH175 Infrared Forehead Thermometer is FLL.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K163516Braun No Touch + Forehead NTF3000 Thermometer K161933The Braun ThermoScan® 3 High Speed Compact Ear 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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.