FDA 510(k)

儀器用於LINK MEGASYSTEM-C 系列家族

K 號：K190181 · 2019-10-25

決定日期2019-10-25

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

Instruments for LINK MEGASYSTEM-C Family is the device name listed in this FDA 510(k) record. The listed applicant is LinkBio Corp.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K190181. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Instruments for LINK MEGASYSTEM-C Family?

Instruments for LINK MEGASYSTEM-C Family is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is LinkBio Corp.. The 510(k) number is K190181.

When did Instruments for LINK MEGASYSTEM-C Family receive FDA 510(k) clearance?

Instruments for LINK MEGASYSTEM-C Family received FDA 510(k) clearance on 2019-10-25, under 510(k) number K190181.

Who is the listed applicant for Instruments for LINK MEGASYSTEM-C Family?

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

What is the FDA product code for Instruments for LINK MEGASYSTEM-C Family?

The FDA product code for Instruments for LINK MEGASYSTEM-C Family is KRO.

其他以 LinkBio Corp. 為申請人之記錄

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K241470核心肩部系統

相關器械（代碼：KRO）

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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