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)

DC-Air 和 Athlos-1 及 Athlos-Air

K 號:K211688 · 2021-07-22

申請人Athlos OY
決定日期2021-07-22
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

DC-Air and Athlos-1 and Athlos-Air is the device name listed in this FDA 510(k) record. The listed applicant is Athlos OY. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K211688. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DC-Air and Athlos-1 and Athlos-Air?

DC-Air and Athlos-1 and Athlos-Air is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Athlos OY. The 510(k) number is K211688.

When did DC-Air and Athlos-1 and Athlos-Air receive FDA 510(k) clearance?

DC-Air and Athlos-1 and Athlos-Air received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211688.

Who is the listed applicant for DC-Air and Athlos-1 and Athlos-Air?

The FDA 510(k) record lists Athlos OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-Air and Athlos-1 and Athlos-Air?

The FDA product code for DC-Air and Athlos-1 and Athlos-Air is MUH.

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:MUH)

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。

↑