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FDA 510(k)

德瑪-R 膦霜(德瑪-R 膦霜)

K 號:K240722 · 2024-09-20

決定日期2024-09-20
產品代碼FRO
決定相當於

器材摘要

Derma-R Cream (Derma-R Cream) is the device name listed in this FDA 510(k) record. The listed applicant is Raya Pharmaceuticals, LLC. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240722. 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 Derma-R Cream (Derma-R Cream)?

Derma-R Cream (Derma-R Cream) is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Raya Pharmaceuticals, LLC. The 510(k) number is K240722.

When did Derma-R Cream (Derma-R Cream) receive FDA 510(k) clearance?

Derma-R Cream (Derma-R Cream) received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240722.

Who is the listed applicant for Derma-R Cream (Derma-R Cream)?

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

What is the FDA product code for Derma-R Cream (Derma-R Cream)?

The FDA product code for Derma-R Cream (Derma-R Cream) is FRO. This falls under the Anesthesiology category.

相關臨床試驗

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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。

官方來源

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