FDA 510(k)

Medical electronic thermometer (FC01, FC02)

N.º K: K240109 · 2024-04-12

SolicitanteZhuzhou Goldenhot Medical Technology Co., Ltd.

Fecha de decisión2024-04-12

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical electronic thermometer (FC01, FC02) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240109. 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 Medical electronic thermometer (FC01, FC02)?

Medical electronic thermometer (FC01, FC02) is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K240109.

When did Medical electronic thermometer (FC01, FC02) receive FDA 510(k) clearance?

Medical electronic thermometer (FC01, FC02) received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240109.

Who is the listed applicant for Medical electronic thermometer (FC01, FC02)?

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

What is the FDA product code for Medical electronic thermometer (FC01, FC02)?

The FDA product code for Medical electronic thermometer (FC01, FC02) is FLL.

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Otros registros que enlistan a Zhuzhou Goldenhot Medical Technology Co., Ltd. como solicitante

K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)K231613Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

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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