FDA 510(k)

Revitive Medic Plus, Revitive Advanced 2

K 號：K190924 · 2019-07-05

決定日期2019-07-05

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Revitive Medic Plus, Revitive Advanced 2 is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190924. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Revitive Medic Plus, Revitive Advanced 2?

Revitive Medic Plus, Revitive Advanced 2 is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Actegy , Ltd.. The 510(k) number is K190924.

When did Revitive Medic Plus, Revitive Advanced 2 receive FDA 510(k) clearance?

Revitive Medic Plus, Revitive Advanced 2 received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190924.

Who is the listed applicant for Revitive Medic Plus, Revitive Advanced 2?

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

What is the FDA product code for Revitive Medic Plus, Revitive Advanced 2?

The FDA product code for Revitive Medic Plus, Revitive Advanced 2 is NGX.

其他以 Actegy , Ltd. 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。

K210825Revitive醫療教練（型號編號 5575AQ）K192887Revitive Medic Plus, Revitive Advanced 2 K152480Revitive 藥品；Revitive MV；Revitive LV

相關器械（代碼：NGX）

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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