FDA 510(k)

清醒自我測試

K 號：K250609 · 2025-09-15

決定日期2025-09-15

產品代碼DIC

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決定相當於

器材摘要

Sober Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Sober Ip, LLC. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K250609. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sober Self-Test?

Sober Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is Sober Ip, LLC. The 510(k) number is K250609.

When did Sober Self-Test receive FDA 510(k) clearance?

Sober Self-Test received FDA 510(k) clearance on 2025-09-15, under 510(k) number K250609.

Who is the listed applicant for Sober Self-Test?

The FDA 510(k) record lists Sober Ip, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sober Self-Test?

The FDA product code for Sober Self-Test is DIC.

相關器械（代碼：DIC）

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官方來源

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