FDA 510(k)

Aingeal 活动系统

K 號：K153275 · 2016-02-26

決定日期2016-02-26

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Aingeal Activity System is the device name listed in this FDA 510(k) record. The listed applicant is Intelesens, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K153275. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aingeal Activity System?

Aingeal Activity System is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Intelesens, Ltd.. The 510(k) number is K153275.

When did Aingeal Activity System receive FDA 510(k) clearance?

Aingeal Activity System received FDA 510(k) clearance on 2016-02-26, under 510(k) number K153275.

Who is the listed applicant for Aingeal Activity System?

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

What is the FDA product code for Aingeal Activity System?

The FDA product code for Aingeal Activity System is MHX.

相關器械（代碼：MHX）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：MHX）

官方來源