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FDA 510(k)

AuraGen 123 吸脂雕塑系統 (A123)

K 號:K190278 · 2019-05-03

決定日期2019-05-03
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

AuraGen 123 Suction Lipoplasty System (A123) is the device name listed in this FDA 510(k) record. The listed applicant is Auragen Aesthetics, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190278. 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 AuraGen 123 Suction Lipoplasty System (A123)?

AuraGen 123 Suction Lipoplasty System (A123) is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Auragen Aesthetics, LLC. The 510(k) number is K190278.

When did AuraGen 123 Suction Lipoplasty System (A123) receive FDA 510(k) clearance?

AuraGen 123 Suction Lipoplasty System (A123) received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190278.

Who is the listed applicant for AuraGen 123 Suction Lipoplasty System (A123)?

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

What is the FDA product code for AuraGen 123 Suction Lipoplasty System (A123)?

The FDA product code for AuraGen 123 Suction Lipoplasty System (A123) is MUU.

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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。

官方來源

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