FDA 510(k)

ANDI 2.2

K 號：K261405 · 2026-05-28

決定日期2026-05-28

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

ANDI 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Imeka Solutions, Inc.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K261405. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANDI 2.2?

ANDI 2.2 is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Imeka Solutions, Inc.. The 510(k) number is K261405.

When did ANDI 2.2 receive FDA 510(k) clearance?

ANDI 2.2 received FDA 510(k) clearance on 2026-05-28, under 510(k) number K261405.

Who is the listed applicant for ANDI 2.2?

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

What is the FDA product code for ANDI 2.2?

The FDA product code for ANDI 2.2 is QIH.

其他以 Imeka Solutions, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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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