FDA 510(k)

icobrain-ctp

K 號：K192962 · 2020-02-28

決定日期2020-02-28

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

icobrain-ctp is the device name listed in this FDA 510(k) record. The listed applicant is Icometrix NV. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192962. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the icobrain-ctp?

icobrain-ctp is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Icometrix NV. The 510(k) number is K192962.

When did icobrain-ctp receive FDA 510(k) clearance?

icobrain-ctp received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192962.

Who is the listed applicant for icobrain-ctp?

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

What is the FDA product code for icobrain-ctp?

The FDA product code for icobrain-ctp is LLZ.

其他以 Icometrix NV 為申請人之記錄

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相關器械（代碼：LLZ）

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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官方來源

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