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)

AccuContour

K 號:K191928 · 2020-02-28

決定日期2020-02-28
產品代碼QKB
諮詢委員會RA
決定相當於

器材摘要

AccuContour is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Manteia Technology , Ltd.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K191928. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AccuContour?

AccuContour is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Xiamen Manteia Technology , Ltd.. The 510(k) number is K191928.

When did AccuContour receive FDA 510(k) clearance?

AccuContour received FDA 510(k) clearance on 2020-02-28, under 510(k) number K191928.

Who is the listed applicant for AccuContour?

The FDA 510(k) record lists Xiamen Manteia Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuContour?

The FDA product code for AccuContour is QKB.

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:QKB)

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。

↑