FDA 510(k)

A-Link Z

K 號：K201671 · 2021-05-04

決定日期2021-05-04

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

A-Link Z is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K201671. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the A-Link Z?

A-Link Z is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K201671.

When did A-Link Z receive FDA 510(k) clearance?

A-Link Z received FDA 510(k) clearance on 2021-05-04, under 510(k) number K201671.

Who is the listed applicant for A-Link Z?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-Link Z?

The FDA product code for A-Link Z is OVD.

其他以 Acuity Surgical Devices, LLC 為申請人之記錄

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相關器械（代碼：OVD）

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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