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FDA 510(k)

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

K-Number: K253109 · 2026-01-07

ApplicantShenzhen Best Electronics Co., Ltd.
Decision Date2026-01-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Best Electronics Co., Ltd.. The 510(k) number is K253109.

When was Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) approved by the FDA?

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

What company makes Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)?

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) is manufactured by Shenzhen Best Electronics Co., Ltd..

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.

Related Clinical Trials

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Other Devices by Shenzhen Best Electronics Co., Ltd.

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)

Related Devices (Code: DQA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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