FDA 510(k)

Revitive 藥品；Revitive MV；Revitive LV

K 號：K152480 · 2016-03-31

決定日期2016-03-31

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Revitive Medic; Revitive MV; Revitive LV is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K152480. 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; Revitive MV; Revitive LV?

Revitive Medic; Revitive MV; Revitive LV is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Actegy , Ltd.. The 510(k) number is K152480.

When did Revitive Medic; Revitive MV; Revitive LV receive FDA 510(k) clearance?

Revitive Medic; Revitive MV; Revitive LV received FDA 510(k) clearance on 2016-03-31, under 510(k) number K152480.

Who is the listed applicant for Revitive Medic; Revitive MV; Revitive LV?

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; Revitive MV; Revitive LV?

The FDA product code for Revitive Medic; Revitive MV; Revitive LV 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 K190924Revitive Medic Plus, Revitive Advanced 2

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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