FDA 510(k)

研發系列 Nova Compo-B Plus 瓶，研發系列 Nova Compo-B Plus 单剂量

K 號：K192913 · 2021-01-19

申請人Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

決定日期2021-01-19

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K192913. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K192913.

When did R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose receive FDA 510(k) clearance?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose received FDA 510(k) clearance on 2021-01-19, under 510(k) number K192913.

Who is the listed applicant for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

The FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is KLE.

其他以 Imicryl Dis Malzemeleri Sanayi VE Ticaret AS 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：KLE）

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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