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FDA 510(k)

Stryker CrossFlow 集成關節鏡抽水機

K 號:K191259 · 2019-07-12

申請人Stryker Corp.
決定日期2019-07-12
產品代碼HRX
諮詢委員會或
決定相當於

器材摘要

Stryker CrossFlow Integrated Arthroscopy Pump is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191259. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stryker CrossFlow Integrated Arthroscopy Pump?

Stryker CrossFlow Integrated Arthroscopy Pump is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Stryker Corp.. The 510(k) number is K191259.

When did Stryker CrossFlow Integrated Arthroscopy Pump receive FDA 510(k) clearance?

Stryker CrossFlow Integrated Arthroscopy Pump received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191259.

Who is the listed applicant for Stryker CrossFlow Integrated Arthroscopy Pump?

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

What is the FDA product code for Stryker CrossFlow Integrated Arthroscopy Pump?

The FDA product code for Stryker CrossFlow Integrated Arthroscopy Pump is HRX.

相關臨床試驗

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其他以 Stryker Corp. 為申請人之記錄

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。

相關器械(代碼:HRX)

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。

官方來源

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