FDA 510(k)

APEX 6

K 號：K220122 · 2023-03-15

決定日期2023-03-15

產品代碼GXD

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

APEX 6 is the device name listed in this FDA 510(k) record. The listed applicant is Rf Innovations, Inc.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K220122. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APEX 6?

APEX 6 is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Rf Innovations, Inc.. The 510(k) number is K220122.

When did APEX 6 receive FDA 510(k) clearance?

APEX 6 received FDA 510(k) clearance on 2023-03-15, under 510(k) number K220122.

Who is the listed applicant for APEX 6?

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

What is the FDA product code for APEX 6?

The FDA product code for APEX 6 is GXD.

相關器械（代碼：GXD）

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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