FDA 510(k)

Idys ALIF TiVac

K 號：K191263 · 2019-06-06

決定日期2019-06-06

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Idys ALIF TiVac is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2019-06-06 under 510(k) number K191263. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Idys ALIF TiVac?

Idys ALIF TiVac is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is Clariance, Sas. The 510(k) number is K191263.

When did Idys ALIF TiVac receive FDA 510(k) clearance?

Idys ALIF TiVac received FDA 510(k) clearance on 2019-06-06, under 510(k) number K191263.

Who is the listed applicant for Idys ALIF TiVac?

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

What is the FDA product code for Idys ALIF TiVac?

The FDA product code for Idys ALIF TiVac is OVD.

其他以 Clariance, Sas 為申請人之記錄

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相關器械（代碼：OVD）

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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