FDA 510(k)

伊克沙娜

K 號：K230249 · 2023-10-16

決定日期2023-10-16

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Ikshana is the device name listed in this FDA 510(k) record. The listed applicant is Immersivetouch. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K230249. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ikshana?

Ikshana is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Immersivetouch. The 510(k) number is K230249.

When did Ikshana receive FDA 510(k) clearance?

Ikshana received FDA 510(k) clearance on 2023-10-16, under 510(k) number K230249.

Who is the listed applicant for Ikshana?

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

What is the FDA product code for Ikshana?

The FDA product code for Ikshana is LLZ.

其他以 Immersivetouch 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。

K181813沉浸式視覺手術計畫 (IVSP®)

相關器械（代碼：LLZ）

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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