FDA 510(k)

CS 模型+

K 號：K193390 · 2020-04-02

申請人Trophy

決定日期2020-04-02

產品代碼PNN

諮詢委員會DE

決定相當於

器材摘要

CS Model+ is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K193390. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CS Model+?

CS Model+ is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Trophy. The 510(k) number is K193390.

When did CS Model+ receive FDA 510(k) clearance?

CS Model+ received FDA 510(k) clearance on 2020-04-02, under 510(k) number K193390.

Who is the listed applicant for CS Model+?

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

What is the FDA product code for CS Model+?

The FDA product code for CS Model+ is PNN.

其他以 Trophy 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。

K200183CS 9600 K181136CS 9600 K173622CS影像設備

相關器械（代碼：PNN）

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。

K262196Invisalign 系統Align Technology, Inc.K260419LingOral 齿科設計系統Hangzhou ChohoTech Co., Ltd.K253565SureSmile 軟體Dentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLC K253343Celebrace軟體Celebrace K250198勞恩正骨科Laon Medi, Inc.

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。