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)

Vitalograph 模型 6000 Alpha

K 號:K212938 · 2022-01-26

決定日期2022-01-26
產品代碼BZG
諮詢委員會AN
決定相當於

器材摘要

Vitalograph Model 6000 Alpha is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212938. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vitalograph Model 6000 Alpha?

Vitalograph Model 6000 Alpha is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K212938.

When did Vitalograph Model 6000 Alpha receive FDA 510(k) clearance?

Vitalograph Model 6000 Alpha received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212938.

Who is the listed applicant for Vitalograph Model 6000 Alpha?

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

What is the FDA product code for Vitalograph Model 6000 Alpha?

The FDA product code for Vitalograph Model 6000 Alpha is BZG.

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。

其他以 Vitalograph Ireland, Ltd. 為申請人之記錄

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:BZG)

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。

↑