FDA 510(k)

Fujifilm Sonosite Vevo MD Imaging System

Numéro K : K160674 · 2016-04-19

Date de décision2016-04-19

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Fujifilm Sonosite Vevo MD Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K160674. 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 Fujifilm Sonosite Vevo MD Imaging System?

Fujifilm Sonosite Vevo MD Imaging System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K160674.

When did Fujifilm Sonosite Vevo MD Imaging System receive FDA 510(k) clearance?

Fujifilm Sonosite Vevo MD Imaging System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K160674.

Who is the listed applicant for Fujifilm Sonosite Vevo MD Imaging System?

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

What is the FDA product code for Fujifilm Sonosite Vevo MD Imaging System?

The FDA product code for Fujifilm Sonosite Vevo MD Imaging System is IYN.

Essais cliniques associés

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Autres dossiers indiquant FUJIFILM Sonosite, Inc. en tant que demandeur

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Dispositifs connexes (Code : IYN)

Source officielle

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