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FDA 510(k)

Sterile Disposable Temperature Probe

N.º K: K212945 · 2022-03-01

SolicitanteShenzhen Envisen Industry Co., Ltd.
Fecha de decisión2022-03-01
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Envisen Industry Co., Ltd.. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K212945. 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 Sterile Disposable Temperature Probe?

Sterile Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Shenzhen Envisen Industry Co., Ltd.. The 510(k) number is K212945.

When did Sterile Disposable Temperature Probe receive FDA 510(k) clearance?

Sterile Disposable Temperature Probe received FDA 510(k) clearance on 2022-03-01, under 510(k) number K212945.

Who is the listed applicant for Sterile Disposable Temperature Probe?

The FDA 510(k) record lists Shenzhen Envisen Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Disposable Temperature Probe?

The FDA product code for Sterile Disposable Temperature Probe 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

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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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