FDA 510(k)

PrisMax系統版本2

K 號：K190910 · 2019-07-25

決定日期2019-07-25

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

PrisMax System Version 2 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K190910. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PrisMax System Version 2?

PrisMax System Version 2 is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K190910.

When did PrisMax System Version 2 receive FDA 510(k) clearance?

PrisMax System Version 2 received FDA 510(k) clearance on 2019-07-25, under 510(k) number K190910.

Who is the listed applicant for PrisMax System Version 2?

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

What is the FDA product code for PrisMax System Version 2?

The FDA product code for PrisMax System Version 2 is KDI.

其他以 Baxter Healthcare Corp 為申請人之記錄

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K163530PrisMax控制單元

相關器械（代碼：KDI）

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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