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FDA 510(k)

軟波Vue

K 號：K172256 · 2018-03-02

申請人Delphinus Medical Technologies
決定日期2018-03-02
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

SoftVue is the device name listed in this FDA 510(k) record. The listed applicant is Delphinus Medical Technologies. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172256. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SoftVue?

SoftVue is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Delphinus Medical Technologies. The 510(k) number is K172256.

When did SoftVue receive FDA 510(k) clearance?

SoftVue received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172256.

Who is the listed applicant for SoftVue?

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

What is the FDA product code for SoftVue?

The FDA product code for SoftVue is IYO.

相關臨床試驗

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相關器械（代碼：IYO）

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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