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FDA 510(k)

Infrared Forehead Thermometer, model: HS-9802D

N.º K: K213038 · 2022-03-10

SolicitanteJiaxing Shangjia Intelligence Technology Co., Ltd.
Fecha de decisión2022-03-10
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Forehead Thermometer, model: HS-9802D is the device name listed in this FDA 510(k) record. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213038. 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 Infrared Forehead Thermometer, model: HS-9802D?

Infrared Forehead Thermometer, model: HS-9802D is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. The 510(k) number is K213038.

When did Infrared Forehead Thermometer, model: HS-9802D receive FDA 510(k) clearance?

Infrared Forehead Thermometer, model: HS-9802D received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213038.

Who is the listed applicant for Infrared Forehead Thermometer, model: HS-9802D?

The FDA 510(k) record lists Jiaxing Shangjia Intelligence Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer, model: HS-9802D?

The FDA product code for Infrared Forehead Thermometer, model: HS-9802D 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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