FDA 510(k)

EP 粒狀™ BVF

K 號：K180853 · 2018-08-06

決定日期2018-08-06

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

EP Granules™ BVF is the device name listed in this FDA 510(k) record. The listed applicant is Elute, Inc.. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K180853. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EP Granules™ BVF?

EP Granules™ BVF is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Elute, Inc.. The 510(k) number is K180853.

When did EP Granules™ BVF receive FDA 510(k) clearance?

EP Granules™ BVF received FDA 510(k) clearance on 2018-08-06, under 510(k) number K180853.

Who is the listed applicant for EP Granules™ BVF?

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

What is the FDA product code for EP Granules™ BVF?

The FDA product code for EP Granules™ BVF is MQV.

其他以 Elute, Inc. 為申請人之記錄

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K250346BonVie+

相關器械（代碼：MQV）

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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