FDA 510(k)

Bonvadis 局部塗劑

K 號：K212554 · 2022-08-19

決定日期2022-08-19

產品代碼FRO

決定相當於

器材摘要

Bonvadis Topical Cream is the device name listed in this FDA 510(k) record. The listed applicant is Stemcyte, Inc.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K212554. 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 Topical Cream?

Bonvadis Topical Cream is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Stemcyte, Inc.. The 510(k) number is K212554.

When did Bonvadis Topical Cream receive FDA 510(k) clearance?

Bonvadis Topical Cream received FDA 510(k) clearance on 2022-08-19, under 510(k) number K212554.

Who is the listed applicant for Bonvadis Topical Cream?

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 Topical Cream?

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

其他以 Stemcyte, Inc. 為申請人之記錄

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K232655Bonvadis®

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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