FDA 510(k)

DeepBT Detector-Plus

Número K: K252190 · 2026-04-10

RequerenteAitewan Biomedical Technology, Inc.

Data da decisão2026-04-10

Código do produtoQKB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

DeepBT Detector-Plus is the device name listed in this FDA 510(k) record. The listed applicant is Aitewan Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252190. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DeepBT Detector-Plus?

DeepBT Detector-Plus is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Aitewan Biomedical Technology, Inc.. The 510(k) number is K252190.

When did DeepBT Detector-Plus receive FDA 510(k) clearance?

DeepBT Detector-Plus received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252190.

Who is the listed applicant for DeepBT Detector-Plus?

The FDA 510(k) record lists Aitewan Biomedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepBT Detector-Plus?

The FDA product code for DeepBT Detector-Plus is QKB.

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