FDA 510(k)

Elation Pulmonary Balloon Dilation

K 號：K161392 · 2016-09-01

決定日期2016-09-01

產品代碼KTI

諮詢委員會EN

決定Substantially Equivalent

器材摘要

Elation Pulmonary Balloon Dilation is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161392. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elation Pulmonary Balloon Dilation?

Elation Pulmonary Balloon Dilation is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K161392.

When did Elation Pulmonary Balloon Dilation receive FDA 510(k) clearance?

Elation Pulmonary Balloon Dilation received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161392.

Who is the listed applicant for Elation Pulmonary Balloon Dilation?

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

What is the FDA product code for Elation Pulmonary Balloon Dilation?

The FDA product code for Elation Pulmonary Balloon Dilation is KTI.

其他以 Merit Medical Systems, Inc. 為申請人之記錄

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相關器械（代碼：KTI）

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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