FDA 510(k)

VS3-鐵鴿系統 (VS3-IR)

K 號：K223020 · 2022-10-28

決定日期2022-10-28

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

VS3-Iridium System (VS3-IR) is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223020. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VS3-Iridium System (VS3-IR)?

VS3-Iridium System (VS3-IR) is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Visionsense, Ltd.. The 510(k) number is K223020.

When did VS3-Iridium System (VS3-IR) receive FDA 510(k) clearance?

VS3-Iridium System (VS3-IR) received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223020.

Who is the listed applicant for VS3-Iridium System (VS3-IR)?

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

What is the FDA product code for VS3-Iridium System (VS3-IR)?

The FDA product code for VS3-Iridium System (VS3-IR) is OWN.

其他以 Visionsense, Ltd. 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。

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相關器械（代碼：OWN）

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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