FDA 510(k)

ManaFlexx 2（型號：MF002-RX、MF002-OTC）

K 號：K231569 · 2023-11-03

決定日期2023-11-03

產品代碼NUH

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

ManaFlexx 2 (model: MF002-RX, MF002-OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231569. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ManaFlexx 2 (model: MF002-RX, MF002-OTC)?

ManaFlexx 2 (model: MF002-RX, MF002-OTC) is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Manamed, Inc.. The 510(k) number is K231569.

When did ManaFlexx 2 (model: MF002-RX, MF002-OTC) receive FDA 510(k) clearance?

ManaFlexx 2 (model: MF002-RX, MF002-OTC) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231569.

Who is the listed applicant for ManaFlexx 2 (model: MF002-RX, MF002-OTC)?

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

What is the FDA product code for ManaFlexx 2 (model: MF002-RX, MF002-OTC)?

The FDA product code for ManaFlexx 2 (model: MF002-RX, MF002-OTC) is NUH.

其他以 Manamed, Inc. 為申請人之記錄

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相關器械（代碼：NUH）

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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