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FDA 510(k)

MIRARI®冷等离子體系統 (GV-M2-01)

K 號:K242553 · 2024-11-21

決定日期2024-11-21
產品代碼PBX
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

MIRARI® Cold Plasma System ( GV-M2-01) is the device name listed in this FDA 510(k) record. The listed applicant is General Vibronics, Inc.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K242553. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MIRARI® Cold Plasma System ( GV-M2-01)?

MIRARI® Cold Plasma System ( GV-M2-01) is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is General Vibronics, Inc.. The 510(k) number is K242553.

When did MIRARI® Cold Plasma System ( GV-M2-01) receive FDA 510(k) clearance?

MIRARI® Cold Plasma System ( GV-M2-01) received FDA 510(k) clearance on 2024-11-21, under 510(k) number K242553.

Who is the listed applicant for MIRARI® Cold Plasma System ( GV-M2-01)?

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

What is the FDA product code for MIRARI® Cold Plasma System ( GV-M2-01)?

The FDA product code for MIRARI® Cold Plasma System ( GV-M2-01) is PBX.

相關臨床試驗

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相關器械(代碼:PBX)

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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