FDA 510(k)

Fetal Doppler U8-25, U9-25

Número K: K252669 · 2026-01-08

RequerenteZhongshan Xiaolan Town Senlan Electronic Factory

Data da decisão2026-01-08

Código do produtoKNG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fetal Doppler U8-25, U9-25 is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K252669. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fetal Doppler U8-25, U9-25?

Fetal Doppler U8-25, U9-25 is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. The 510(k) number is K252669.

When did Fetal Doppler U8-25, U9-25 receive FDA 510(k) clearance?

Fetal Doppler U8-25, U9-25 received FDA 510(k) clearance on 2026-01-08, under 510(k) number K252669.

Who is the listed applicant for Fetal Doppler U8-25, U9-25?

The FDA 510(k) record lists Zhongshan Xiaolan Town Senlan Electronic Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal Doppler U8-25, U9-25?

The FDA product code for Fetal Doppler U8-25, U9-25 is KNG.

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Dispositivos Relacionados (Código: KNG)

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