免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

NEOCERA先進防護乳膏

K 號:K170911 · 2017-08-22

決定日期2017-08-22
產品代碼FRO
決定相當於

器材摘要

NEOCERA Advanced Barrier Cream is the device name listed in this FDA 510(k) record. The listed applicant is Exeltis USA Dermatology, LLC. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K170911. 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 NEOCERA Advanced Barrier Cream?

NEOCERA Advanced Barrier Cream is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Exeltis USA Dermatology, LLC. The 510(k) number is K170911.

When did NEOCERA Advanced Barrier Cream receive FDA 510(k) clearance?

NEOCERA Advanced Barrier Cream received FDA 510(k) clearance on 2017-08-22, under 510(k) number K170911.

Who is the listed applicant for NEOCERA Advanced Barrier Cream?

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

What is the FDA product code for NEOCERA Advanced Barrier Cream?

The FDA product code for NEOCERA Advanced Barrier Cream is FRO. This falls under the Anesthesiology category.

相關臨床試驗

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。

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑