FDA 510(k)

威爾遜-庫克胃食管失弛緩症機器球

K 號：K182895 · 2019-01-25

決定日期2019-01-25

產品代碼PID

諮詢委員會GU

決定相當於

器材摘要

Wilson-Cook Achalasia Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182895. The device is classified under product code PID. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wilson-Cook Achalasia Balloon?

Wilson-Cook Achalasia Balloon is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K182895.

When did Wilson-Cook Achalasia Balloon receive FDA 510(k) clearance?

Wilson-Cook Achalasia Balloon received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182895.

Who is the listed applicant for Wilson-Cook Achalasia Balloon?

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

What is the FDA product code for Wilson-Cook Achalasia Balloon?

The FDA product code for Wilson-Cook Achalasia Balloon is PID.

其他以 Wilson-Cook Medical, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Wilson-Cook Medical, Inc. 為申請人之記錄

官方來源