FDA 510(k)

Stryker 海王星 E-SEP 雾氣抽離筆

K 號：K153679 · 2016-01-22

決定日期2016-01-22

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Stryker Neptune E-SEP Smoke Evacuation Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K153679. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stryker Neptune E-SEP Smoke Evacuation Pencil?

Stryker Neptune E-SEP Smoke Evacuation Pencil is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Stryker Corporation. The 510(k) number is K153679.

When did Stryker Neptune E-SEP Smoke Evacuation Pencil receive FDA 510(k) clearance?

Stryker Neptune E-SEP Smoke Evacuation Pencil received FDA 510(k) clearance on 2016-01-22, under 510(k) number K153679.

Who is the listed applicant for Stryker Neptune E-SEP Smoke Evacuation Pencil?

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

What is the FDA product code for Stryker Neptune E-SEP Smoke Evacuation Pencil?

The FDA product code for Stryker Neptune E-SEP Smoke Evacuation Pencil is GEI.

其他以 Stryker Corporation 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。

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相關器械（代碼：GEI）

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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