FDA 510(k)

Vivid T8, Vivid T9

Numéro K : K181934 · 2018-11-06

DemandeurGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Date de décision2018-11-06

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Vivid T8, Vivid T9 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K181934. 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 Vivid T8, Vivid T9?

Vivid T8, Vivid T9 is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K181934.

When did Vivid T8, Vivid T9 receive FDA 510(k) clearance?

Vivid T8, Vivid T9 received FDA 510(k) clearance on 2018-11-06, under 510(k) number K181934.

Who is the listed applicant for Vivid T8, Vivid T9?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid T8, Vivid T9?

The FDA product code for Vivid T8, Vivid T9 is IYN.

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Dispositifs connexes (Code : IYN)

Source officielle

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