FDA 510(k)

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

Número K: K243000 · 2025-06-20

RequerenteShenzhen Medke Technology Co., Ltd.

Data da decisão2025-06-20

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243000. 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 Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)?

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K243000.

When did Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) receive FDA 510(k) clearance?

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243000.

Who is the listed applicant for Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)?

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

What is the FDA product code for Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)?

The FDA product code for Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) is FLL.

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Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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