FDA 510(k)

諾瓦導引2智能超音波設備

K 號：K213279 · 2022-03-02

決定日期2022-03-02

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

NovaGuide 2 Intelligent Ultrasound is the device name listed in this FDA 510(k) record. The listed applicant is Novasignal Corporation. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213279. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NovaGuide 2 Intelligent Ultrasound?

NovaGuide 2 Intelligent Ultrasound is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Novasignal Corporation. The 510(k) number is K213279.

When did NovaGuide 2 Intelligent Ultrasound receive FDA 510(k) clearance?

NovaGuide 2 Intelligent Ultrasound received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213279.

Who is the listed applicant for NovaGuide 2 Intelligent Ultrasound?

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

What is the FDA product code for NovaGuide 2 Intelligent Ultrasound?

The FDA product code for NovaGuide 2 Intelligent Ultrasound is IYN.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源