FDA 510(k)

Relivion

K 號：K212106 · 2021-08-02

決定日期2021-08-02

產品代碼PCC

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

Relivion is the device name listed in this FDA 510(k) record. The listed applicant is Neurolief , Ltd.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K212106. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Relivion?

Relivion is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Neurolief , Ltd.. The 510(k) number is K212106.

When did Relivion receive FDA 510(k) clearance?

Relivion received FDA 510(k) clearance on 2021-08-02, under 510(k) number K212106.

Who is the listed applicant for Relivion?

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

What is the FDA product code for Relivion?

The FDA product code for Relivion is PCC.

其他以 Neurolief , Ltd. 為申請人之記錄

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K203419Relivion

相關器械（代碼：PCC）

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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