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FDA 510(k)

選擇2 DC

K 號:K250156 · 2025-07-11

申請人Bisco, Inc.
決定日期2025-07-11
產品代碼EMA
諮詢委員會DE
決定相當於

器材摘要

Choice 2 DC is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250156. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Choice 2 DC?

Choice 2 DC is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Bisco, Inc.. The 510(k) number is K250156.

When did Choice 2 DC receive FDA 510(k) clearance?

Choice 2 DC received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250156.

Who is the listed applicant for Choice 2 DC?

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

What is the FDA product code for Choice 2 DC?

The FDA product code for Choice 2 DC is EMA.

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其他以 Bisco, Inc. 為申請人之記錄

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相關器械(代碼:EMA)

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官方來源

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