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FDA 510(k)

M-Y 套管

K 號:K190369 · 2019-04-17

決定日期2019-04-17
產品代碼DYB
諮詢委員會履歷
決定相當於

器材摘要

M-Y Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Ram Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K190369. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M-Y Sheath?

M-Y Sheath is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ram Medical Innovations, Inc.. The 510(k) number is K190369.

When did M-Y Sheath receive FDA 510(k) clearance?

M-Y Sheath received FDA 510(k) clearance on 2019-04-17, under 510(k) number K190369.

Who is the listed applicant for M-Y Sheath?

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

What is the FDA product code for M-Y Sheath?

The FDA product code for M-Y Sheath is DYB.

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相關器械(代碼:DYB)

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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