FDA 510(k)

神經Q 3.8

K 號：K180077 · 2018-08-16

決定日期2018-08-16

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

NeuroQ 3.8 is the device name listed in this FDA 510(k) record. The listed applicant is Syntermed. It received FDA 510(k) clearance on 2018-08-16 under 510(k) number K180077. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroQ 3.8?

NeuroQ 3.8 is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Syntermed. The 510(k) number is K180077.

When did NeuroQ 3.8 receive FDA 510(k) clearance?

NeuroQ 3.8 received FDA 510(k) clearance on 2018-08-16, under 510(k) number K180077.

Who is the listed applicant for NeuroQ 3.8?

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

What is the FDA product code for NeuroQ 3.8?

The FDA product code for NeuroQ 3.8 is KPS.

其他以 Syntermed 為申請人之記錄

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相關器械（代碼：KPS）

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官方來源

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