FDA 510(k)

Bonvadis®

K 號：K232655 · 2024-05-22

決定日期2024-05-22

產品代碼FRO

決定相當於

器材摘要

Bonvadis® is the device name listed in this FDA 510(k) record. The listed applicant is Stemcyte, Inc.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K232655. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Bonvadis®?

Bonvadis® is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Stemcyte, Inc.. The 510(k) number is K232655.

When did Bonvadis® receive FDA 510(k) clearance?

Bonvadis® received FDA 510(k) clearance on 2024-05-22, under 510(k) number K232655.

Who is the listed applicant for Bonvadis®?

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

What is the FDA product code for Bonvadis®?

The FDA product code for Bonvadis® is FRO. This falls under the Anesthesiology category.

其他以 Stemcyte, Inc. 為申請人之記錄

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K212554Bonvadis 局部塗劑

相關器械（代碼：FRO）

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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