FDA 510(k)

初始立思普醫療設備規範文本

K 號：K153136 · 2016-06-30

決定日期2016-06-30

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Initial LiSi Press is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153136. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Initial LiSi Press?

Initial LiSi Press is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is GC America, Inc.. The 510(k) number is K153136.

When did Initial LiSi Press receive FDA 510(k) clearance?

Initial LiSi Press received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153136.

Who is the listed applicant for Initial LiSi Press?

FDA 510(k) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Initial LiSi Press?

The FDA product code for Initial LiSi Press is EIH.

其他以 GC America, Inc. 為申請人之記錄

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相關器械（代碼：EIH）

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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