FDA 510(k)

Axon 療法

K 號：K210021 · 2021-06-11

決定日期2021-06-11

產品代碼QPL

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

Axon Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Neuralace Medical, Inc.. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210021. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Axon Therapy?

Axon Therapy is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Neuralace Medical, Inc.. The 510(k) number is K210021.

When did Axon Therapy receive FDA 510(k) clearance?

Axon Therapy received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210021.

Who is the listed applicant for Axon Therapy?

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

What is the FDA product code for Axon Therapy?

The FDA product code for Axon Therapy is QPL.

其他以 Neuralace Medical, Inc. 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。

K233364Axon 療法

相關器械（代碼：QPL）

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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