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FDA 510(k)

SR-8230, SR-8230S 隨身 X 光單位

K 號：K200976 · 2020-06-10

申請人Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
決定日期2020-06-10
產品代碼IZL
諮詢委員會RA
決定相當於

器材摘要

SR-8230, SR-8230S Portable X-ray Unit 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 2020-06-10 under 510(k) number K200976. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SR-8230, SR-8230S Portable X-ray Unit?

SR-8230, SR-8230S Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K200976.

When did SR-8230, SR-8230S Portable X-ray Unit receive FDA 510(k) clearance?

SR-8230, SR-8230S Portable X-ray Unit received FDA 510(k) clearance on 2020-06-10, under 510(k) number K200976.

Who is the listed applicant for SR-8230, SR-8230S Portable X-ray Unit?

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 SR-8230, SR-8230S Portable X-ray Unit?

The FDA product code for SR-8230, SR-8230S Portable X-ray Unit is IZL.

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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。

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相關器械（代碼：IZL）

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。

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