FDA 510(k)

HAD1717MC

K 號：K200018 · 2020-01-31

申請人H&Abyz

決定日期2020-01-31

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

HAD1717MC is the device name listed in this FDA 510(k) record. The listed applicant is H&Abyz. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K200018. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAD1717MC?

HAD1717MC is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is H&Abyz. The 510(k) number is K200018.

When did HAD1717MC receive FDA 510(k) clearance?

HAD1717MC received FDA 510(k) clearance on 2020-01-31, under 510(k) number K200018.

Who is the listed applicant for HAD1717MC?

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

What is the FDA product code for HAD1717MC?

The FDA product code for HAD1717MC is MQB.

相關器械（代碼：MQB）

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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