FDA 510(k)

iSyncWave

K 號：K220056 · 2022-08-10

決定日期2022-08-10

產品代碼GWQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

iSyncWave is the device name listed in this FDA 510(k) record. The listed applicant is iMediSync, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K220056. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iSyncWave?

iSyncWave is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is iMediSync, Inc.. The 510(k) number is K220056.

When did iSyncWave receive FDA 510(k) clearance?

iSyncWave received FDA 510(k) clearance on 2022-08-10, under 510(k) number K220056.

Who is the listed applicant for iSyncWave?

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

What is the FDA product code for iSyncWave?

The FDA product code for iSyncWave is GWQ.

其他以 iMediSync, Inc. 為申請人之記錄

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相關器械（代碼：GWQ）

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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