FDA 510(k)

Exsomed 手腕固定系統

K 號：K192473 · 2019-12-03

決定日期2019-12-03

產品代碼HRS

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決定相當於

器材摘要

Exsomed Wrist Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Corporation. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K192473. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Exsomed Wrist Plating System?

Exsomed Wrist Plating System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Exsomed Corporation. The 510(k) number is K192473.

When did Exsomed Wrist Plating System receive FDA 510(k) clearance?

Exsomed Wrist Plating System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192473.

Who is the listed applicant for Exsomed Wrist Plating System?

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

What is the FDA product code for Exsomed Wrist Plating System?

The FDA product code for Exsomed Wrist Plating System is HRS.

其他以 Exsomed Corporation 為申請人之記錄

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K183603INnate 穿刺螺釘系統

相關器械（代碼：HRS）

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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