FDA 510(k)

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Número K: K193338 · 2020-08-25

RequerenteShenzhen Med-Link Electronics Tech Co., Ltd.

Data da decisão2020-08-25

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K193338. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K193338.

When did Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes receive FDA 510(k) clearance?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes received FDA 510(k) clearance on 2020-08-25, under 510(k) number K193338.

Who is the listed applicant for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is FLL.

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Outros registros que listam Shenzhen Med-Link Electronics Tech Co., Ltd. como candidato(a)

K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)K220448Disposable Non-invasive EEG Sensor K220447Med-link Disposable ECG Cable and Leadwires K212752Med-link Pulse Oximeter K210441Incontinence Probe K202743Med-Link Temp-pulse Oxímetro

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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.

Fonte oficial

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