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FDA 510(k)

Presygen/si-1

K 號：K171245 · 2018-08-09

申請人Christie Medical Holdings, Inc.
決定日期2018-08-09
產品代碼MUD
諮詢委員會履歷
決定相當於

器材摘要

Presygen/si-1 is the device name listed in this FDA 510(k) record. The listed applicant is Christie Medical Holdings, Inc.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K171245. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Presygen/si-1?

Presygen/si-1 is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Christie Medical Holdings, Inc.. The 510(k) number is K171245.

When did Presygen/si-1 receive FDA 510(k) clearance?

Presygen/si-1 received FDA 510(k) clearance on 2018-08-09, under 510(k) number K171245.

Who is the listed applicant for Presygen/si-1?

The FDA 510(k) record lists Christie Medical Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Presygen/si-1?

The FDA product code for Presygen/si-1 is MUD.

相關臨床試驗

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相關器械（代碼：MUD）

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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