FDA 510(k)

Ear Thermometer, Model ET005, ET008, ET009

N.º K: K213084 · 2022-02-25

SolicitanteGuangzhou Berrcom Medical Device Co., Ltd.

Fecha de decisión2022-02-25

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ear Thermometer, Model ET005, ET008, ET009 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K213084. 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 Ear Thermometer, Model ET005, ET008, ET009?

Ear Thermometer, Model ET005, ET008, ET009 is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213084.

When did Ear Thermometer, Model ET005, ET008, ET009 receive FDA 510(k) clearance?

Ear Thermometer, Model ET005, ET008, ET009 received FDA 510(k) clearance on 2022-02-25, under 510(k) number K213084.

Who is the listed applicant for Ear Thermometer, Model ET005, ET008, ET009?

The FDA 510(k) record lists Guangzhou Berrcom Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ear Thermometer, Model ET005, ET008, ET009?

The FDA product code for Ear Thermometer, Model ET005, ET008, ET009 is FLL.

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Otros registros que enlistan a Guangzhou Berrcom Medical Device Co., Ltd. como solicitante

K214077Digital Thermometer, Model: DT007, DT008 K213746Digital thermometer, Model DT101, DT102 K213079Ear Thermometer, Model ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K191570Infrared Thermometer Model MD-H30

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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