FDA 510(k)

Apogee 6500,Apogee 6300,Apogee 6200數位彩色多普勒超聲成像系統

K 號：K210318 · 2021-08-18

申請人Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

決定日期2021-08-18

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K210318. 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 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K210318.

When did Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System receive FDA 510(k) clearance?

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance on 2021-08-18, under 510(k) number K210318.

Who is the listed applicant for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?

The FDA product code for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is IYN.

其他以 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) 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。

K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G 選色多普勒超音波成像系統 K202350SR-1000 輕便式DR影像系統，SR-1000S 輕便式DR影像系統 K202353SR-2300 輕便式DR影像系統，SR-2300S 輕便式DR影像系統 K200637SR-8100 輕便式X光機 K200976SR-8230, SR-8230S 隨身 X 光單位 K173000Apogee 2100 選色多普勒超音波成像系統 Apogee 2300 選色多普勒超音波成像系統

查看所有 8 項裝置 →

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。