FDA 510(k)

沉浸式視覺手術計畫 (IVSP®)

K 號：K181813 · 2020-06-09

決定日期2020-06-09

產品代碼DZJ

諮詢委員會DE

決定相當於

器材摘要

ImmersiveView Surgical Plan (IVSP®) is the device name listed in this FDA 510(k) record. The listed applicant is Immersivetouch. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K181813. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ImmersiveView Surgical Plan (IVSP®)?

ImmersiveView Surgical Plan (IVSP®) is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Immersivetouch. The 510(k) number is K181813.

When did ImmersiveView Surgical Plan (IVSP®) receive FDA 510(k) clearance?

ImmersiveView Surgical Plan (IVSP®) received FDA 510(k) clearance on 2020-06-09, under 510(k) number K181813.

Who is the listed applicant for ImmersiveView Surgical Plan (IVSP®)?

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 ImmersiveView Surgical Plan (IVSP®)?

The FDA product code for ImmersiveView Surgical Plan (IVSP®) is DZJ.

其他以 Immersivetouch 為申請人之記錄

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K230249伊克沙娜

相關器械（代碼：DZJ）

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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