FDA 510(k)

Vivid S60N, Vivid S70N

Numéro K : K170878 · 2017-06-14

DemandeurGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Date de décision2017-06-14

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Vivid S60N, Vivid S70N 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 2017-06-14 under 510(k) number K170878. 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 S60N, Vivid S70N?

Vivid S60N, Vivid S70N is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K170878.

When did Vivid S60N, Vivid S70N receive FDA 510(k) clearance?

Vivid S60N, Vivid S70N received FDA 510(k) clearance on 2017-06-14, under 510(k) number K170878.

Who is the listed applicant for Vivid S60N, Vivid S70N?

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 S60N, Vivid S70N?

The FDA product code for Vivid S60N, Vivid S70N is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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