FDA 510(k)

旋轉環境 600 先進脂肪系統

K 號：K163647 · 2017-08-25

決定日期2017-08-25

產品代碼MUU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Revolve Envi 600 Advanced Adipose System is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corporation. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K163647. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Revolve Envi 600 Advanced Adipose System?

Revolve Envi 600 Advanced Adipose System is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Lifecell Corporation. The 510(k) number is K163647.

When did Revolve Envi 600 Advanced Adipose System receive FDA 510(k) clearance?

Revolve Envi 600 Advanced Adipose System received FDA 510(k) clearance on 2017-08-25, under 510(k) number K163647.

Who is the listed applicant for Revolve Envi 600 Advanced Adipose System?

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

What is the FDA product code for Revolve Envi 600 Advanced Adipose System?

The FDA product code for Revolve Envi 600 Advanced Adipose System is MUU.

其他以 Lifecell Corporation 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。

K193539旋轉環境 600 先進脂肪系統 K162752ARTIA 重構組織膠質網孔板

相關器械（代碼：MUU）

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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