FDA 510(k)

Terason uSmart 3200T Plus 超聲波系統

K 號：K201633 · 2020-07-02

決定日期2020-07-02

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Terason uSmart 3200T Plus Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corporation. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K201633. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Terason uSmart 3200T Plus Ultrasound System?

Terason uSmart 3200T Plus Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Teratech Corporation. The 510(k) number is K201633.

When did Terason uSmart 3200T Plus Ultrasound System receive FDA 510(k) clearance?

Terason uSmart 3200T Plus Ultrasound System received FDA 510(k) clearance on 2020-07-02, under 510(k) number K201633.

Who is the listed applicant for Terason uSmart 3200T Plus Ultrasound System?

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

What is the FDA product code for Terason uSmart 3200T Plus Ultrasound System?

The FDA product code for Terason uSmart 3200T Plus Ultrasound System is IYN.

其他以 Teratech Corporation 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。

K193510Terason uSmart3200T 超聲波系統

相關器械（代碼：IYN）

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。