FDA 510(k)

NovaGuide 2 Intelligent Ultrasound

Numéro K : K213279 · 2022-03-02

Date de décision2022-03-02

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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