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FDA 510(k)

VS3-IR

K 號:K191851 · 2019-11-25

申請人Medtronic
決定日期2019-11-25
產品代碼OWN
諮詢委員會GU
決定相當於

器材摘要

VS3-IR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K191851. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VS3-IR?

VS3-IR is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Medtronic. The 510(k) number is K191851.

When did VS3-IR receive FDA 510(k) clearance?

VS3-IR received FDA 510(k) clearance on 2019-11-25, under 510(k) number K191851.

Who is the listed applicant for VS3-IR?

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

What is the FDA product code for VS3-IR?

The FDA product code for VS3-IR is OWN.

其他以 Medtronic 為申請人之記錄

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相關器械(代碼:OWN)

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