FDA 510(k)

微麥特

K 號：K203720 · 2021-06-22

決定日期2021-06-22

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

MICROMATE is the device name listed in this FDA 510(k) record. The listed applicant is Isys Medizintechnik GmbH. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K203720. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MICROMATE?

MICROMATE is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is Isys Medizintechnik GmbH. The 510(k) number is K203720.

When did MICROMATE receive FDA 510(k) clearance?

MICROMATE received FDA 510(k) clearance on 2021-06-22, under 510(k) number K203720.

Who is the listed applicant for MICROMATE?

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

What is the FDA product code for MICROMATE?

The FDA product code for MICROMATE is JAK.

其他以 Isys Medizintechnik GmbH 為申請人之記錄

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相關器械（代碼：JAK）

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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