FDA 510(k)

超音波骨切術系統

K 號：K201274 · 2021-02-19

決定日期2021-02-19

產品代碼JDX

諮詢委員會或

決定相當於

器材摘要

Ultrasonic Osteotomy Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K201274. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultrasonic Osteotomy Surgical System?

Ultrasonic Osteotomy Surgical System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Smtp Technology Co., Ltd.. The 510(k) number is K201274.

When did Ultrasonic Osteotomy Surgical System receive FDA 510(k) clearance?

Ultrasonic Osteotomy Surgical System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K201274.

Who is the listed applicant for Ultrasonic Osteotomy Surgical System?

The FDA 510(k) record lists Smtp Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Osteotomy Surgical System?

The FDA product code for Ultrasonic Osteotomy Surgical System is JDX.

其他以 Smtp Technology Co., Ltd. 為申請人之記錄

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K212750超聲外科吸引器系統，型號：XD880B K202299超音波外科吸引器系統

相關器械（代碼：JDX）

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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官方來源

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