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)

Cufitec外科口罩

K 號:K182766 · 2019-01-03

決定日期2019-01-03
產品代碼OUK
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Cufitec Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Nbc Meshtec, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K182766. The device is classified under product code OUK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cufitec Surgical Mask?

Cufitec Surgical Mask is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Nbc Meshtec, Inc.. The 510(k) number is K182766.

When did Cufitec Surgical Mask receive FDA 510(k) clearance?

Cufitec Surgical Mask received FDA 510(k) clearance on 2019-01-03, under 510(k) number K182766.

Who is the listed applicant for Cufitec Surgical Mask?

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

What is the FDA product code for Cufitec Surgical Mask?

The FDA product code for Cufitec Surgical Mask is OUK.

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:OUK)

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。

↑