Zmaxx T 系列
K 號:K161219 · 2017-01-26
廣告
器材摘要
Zmaxx T Series is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Digm, Inc.. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K161219. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Zmaxx T Series?
Zmaxx T Series is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Maxx Digm, Inc.. The 510(k) number is K161219.
When did Zmaxx T Series receive FDA 510(k) clearance?
Zmaxx T Series received FDA 510(k) clearance on 2017-01-26, under 510(k) number K161219.
Who is the listed applicant for Zmaxx T Series?
The FDA 510(k) record lists Maxx Digm, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zmaxx T Series?
The FDA product code for Zmaxx T Series is EIH.
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:EIH)
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。
廣告