FDA 510(k)

袖套式IC

K 號：K220667 · 2022-12-08

決定日期2022-12-08

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Sleeved IC is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K220667. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sleeved IC?

Sleeved IC is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Hollister Incorporated. The 510(k) number is K220667.

When did Sleeved IC receive FDA 510(k) clearance?

Sleeved IC received FDA 510(k) clearance on 2022-12-08, under 510(k) number K220667.

Who is the listed applicant for Sleeved IC?

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

What is the FDA product code for Sleeved IC?

The FDA product code for Sleeved IC is EZD.

其他以 Hollister Incorporated 為申請人之記錄

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相關器械（代碼：EZD）

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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