FDA 510(k)

電子波

K 號：K211253 · 2021-05-26

決定日期2021-05-26

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

PlasmaWave is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211253. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PlasmaWave?

PlasmaWave is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Manamed, Inc.. The 510(k) number is K211253.

When did PlasmaWave receive FDA 510(k) clearance?

PlasmaWave received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211253.

Who is the listed applicant for PlasmaWave?

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

What is the FDA product code for PlasmaWave?

The FDA product code for PlasmaWave is JOW.

其他以 Manamed, Inc. 為申請人之記錄

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相關器械（代碼：JOW）

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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