FDA 510(k)

可重用SPO2感測器（BSA307-47；BSA109-50；BSA109-31O）

K 號：K253109 · 2026-01-07

決定日期2026-01-07

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shenzhen Best Electronics Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253089NIBP 腕帶 (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)

相關器械（代碼：DQA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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