FDA 510(k)

淸涼

K 號：K152954 · 2016-01-05

決定日期2016-01-05

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Quell is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152954. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quell?

Quell is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is Neurometrix, Inc.. The 510(k) number is K152954.

When did Quell receive FDA 510(k) clearance?

Quell received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152954.

Who is the listed applicant for Quell?

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

What is the FDA product code for Quell?

The FDA product code for Quell is NUH.

相關器械（代碼：NUH）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NUH）

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