FDA 510(k)

MaxiGen

K 號：K152077 · 2016-04-21

決定日期2016-04-21

產品代碼MQV

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決定相當於

器材摘要

MaxiGen is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corp.. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152077. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MaxiGen?

MaxiGen is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Hans Biomed Corp.. The 510(k) number is K152077.

When did MaxiGen receive FDA 510(k) clearance?

MaxiGen received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152077.

Who is the listed applicant for MaxiGen?

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

What is the FDA product code for MaxiGen?

The FDA product code for MaxiGen is MQV.

其他以 Hans Biomed 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。

K151271貝拉融

相關器械（代碼：MQV）

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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