FDA 510(k)

Indego®

K 號：K173530 · 2018-01-31

決定日期2018-01-31

產品代碼PHL

諮詢委員會PM

決定相當於

器材摘要

Indego(R) is the device name listed in this FDA 510(k) record. The listed applicant is Parker-Hannifin Corporation. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K173530. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Indego(R)?

Indego(R) is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Parker-Hannifin Corporation. The 510(k) number is K173530.

When did Indego(R) receive FDA 510(k) clearance?

Indego(R) received FDA 510(k) clearance on 2018-01-31, under 510(k) number K173530.

Who is the listed applicant for Indego(R)?

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

What is the FDA product code for Indego(R)?

The FDA product code for Indego(R) is PHL.

其他以 Parker-Hannifin Corporation 為申請人之記錄

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相關器械（代碼：PHL）

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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