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FDA 510(k)

Qora AIM 大便管理套件,Qora Aeon 大便管理套件,Qora Arida 大便管理套件

K 號:K153506 · 2016-05-06

決定日期2016-05-06
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is the device name listed in this FDA 510(k) record. The listed applicant is Consure Medical Pvt , Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153506. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Consure Medical Pvt , Ltd.. The 510(k) number is K153506.

When did Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit receive FDA 510(k) clearance?

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153506.

Who is the listed applicant for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

The FDA 510(k) record lists Consure Medical Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

The FDA product code for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is KNT.

相關臨床試驗

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。

相關器械(代碼:KNT)

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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