FDA 510(k)

BonVie+

K 號：K250346 · 2025-02-26

決定日期2025-02-26

產品代碼MQV

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決定相當於

器材摘要

BonVie+ is the device name listed in this FDA 510(k) record. The listed applicant is Elute, Inc.. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K250346. 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 BonVie+?

BonVie+ is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Elute, Inc.. The 510(k) number is K250346.

When did BonVie+ receive FDA 510(k) clearance?

BonVie+ received FDA 510(k) clearance on 2025-02-26, under 510(k) number K250346.

Who is the listed applicant for BonVie+?

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 BonVie+?

The FDA product code for BonVie+ is MQV.

其他以 Elute, Inc. 為申請人之記錄

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K180853EP 粒狀™ BVF

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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