FDA 510(k)

IntelliSpace Portal 平台

K 號：K162025 · 2016-10-18

申請人Philips Medical Systems Nederlands B.V.

決定日期2016-10-18

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

IntelliSpace Portal Platform is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162025. 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 IntelliSpace Portal Platform?

IntelliSpace Portal Platform is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K162025.

When did IntelliSpace Portal Platform receive FDA 510(k) clearance?

IntelliSpace Portal Platform received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162025.

Who is the listed applicant for IntelliSpace Portal Platform?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliSpace Portal Platform?

The FDA product code for IntelliSpace Portal Platform is LLZ.

其他以 Philips Medical Systems Nederlands B.V. 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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