FDA 510(k)

7400 Systèmes d'ultrasons

Numéro K : K190447 · 2019-04-01

DemandeurNavigant Consulting - on Behalf of Esaote S.P.A.

Date de décision2019-04-01

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

7400 Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Navigant Consulting - on Behalf of Esaote S.P.A.. It received FDA 510(k) clearance on 2019-04-01 under 510(k) number K190447. 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 7400 Ultrasound Systems?

7400 Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2019-04-01. The listed applicant is Navigant Consulting - on Behalf of Esaote S.P.A.. The 510(k) number is K190447.

When did 7400 Ultrasound Systems receive FDA 510(k) clearance?

7400 Ultrasound Systems received FDA 510(k) clearance on 2019-04-01, under 510(k) number K190447.

Who is the listed applicant for 7400 Ultrasound Systems?

The FDA 510(k) record lists Navigant Consulting - on Behalf of Esaote S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7400 Ultrasound Systems?

The FDA product code for 7400 Ultrasound Systems is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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