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FDA 510(k)

Electronic Thermometer (XHF2001, XHF2002)

N.º K: K211352 · 2021-09-09

SolicitantePutian Hanjiang Huafeng Plastic Co., Ltd.
Fecha de decisión2021-09-09
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Electronic Thermometer (XHF2001, XHF2002) is the device name listed in this FDA 510(k) record. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K211352. 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 Electronic Thermometer (XHF2001, XHF2002)?

Electronic Thermometer (XHF2001, XHF2002) is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. The 510(k) number is K211352.

When did Electronic Thermometer (XHF2001, XHF2002) receive FDA 510(k) clearance?

Electronic Thermometer (XHF2001, XHF2002) received FDA 510(k) clearance on 2021-09-09, under 510(k) number K211352.

Who is the listed applicant for Electronic Thermometer (XHF2001, XHF2002)?

The FDA 510(k) record lists Putian Hanjiang Huafeng Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer (XHF2001, XHF2002)?

The FDA product code for Electronic Thermometer (XHF2001, XHF2002) is FLL.

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Dispositivos relacionados (Código: FLL)

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.

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.

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