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FDA 510(k)

離子雷射發生器

K 號:K201610 · 2020-10-21

決定日期2020-10-21
產品代碼GXD
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

IonicRF Generator is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201610. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IonicRF Generator?

IonicRF Generator is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K201610.

When did IonicRF Generator receive FDA 510(k) clearance?

IonicRF Generator received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201610.

Who is the listed applicant for IonicRF Generator?

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

What is the FDA product code for IonicRF Generator?

The FDA product code for IonicRF Generator is GXD.

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其他以 ABBOTT MEDICAL 為申請人之記錄

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相關器械(代碼:GXD)

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官方來源

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