FDA 510(k)

CASCADE IOMAX 麻醉監護儀

K 號：K162199 · 2017-03-02

決定日期2017-03-02

產品代碼GWF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Cascade IOMAX Intraoperative Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K162199. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cascade IOMAX Intraoperative Monitor?

Cascade IOMAX Intraoperative Monitor is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K162199.

When did Cascade IOMAX Intraoperative Monitor receive FDA 510(k) clearance?

Cascade IOMAX Intraoperative Monitor received FDA 510(k) clearance on 2017-03-02, under 510(k) number K162199.

Who is the listed applicant for Cascade IOMAX Intraoperative Monitor?

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

What is the FDA product code for Cascade IOMAX Intraoperative Monitor?

The FDA product code for Cascade IOMAX Intraoperative Monitor is GWF.

其他以 Cadwell Industries, Inc. 為申請人之記錄

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相關器械（代碼：GWF）

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