FDA 510(k)

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

Número K: K253109 · 2026-01-07

RequerenteShenzhen Best Electronics Co., Ltd.

Data da decisão2026-01-07

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Best Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K253109. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)?

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Shenzhen Best Electronics Co., Ltd.. The 510(k) number is K253109.

When did Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) receive FDA 510(k) clearance?

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253109.

Who is the listed applicant for Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)?

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

What is the FDA product code for Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)?

The FDA product code for Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) is DQA.

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Outros registros que listam Shenzhen Best Electronics Co., Ltd. como candidato(a)

K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

Dispositivos Relacionados (Código: DQA)

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