FDA 510(k)

Venue Fit

Numéro K : K234106 · 2024-06-10

DemandeurGE Medical Systems Ultrasound and Primary Care Diagnostics

Date de décision2024-06-10

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Venue Fit is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-06-10 under 510(k) number K234106. 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 Venue Fit?

Venue Fit is a medical device that received FDA 510(k) clearance on 2024-06-10. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K234106.

When did Venue Fit receive FDA 510(k) clearance?

Venue Fit received FDA 510(k) clearance on 2024-06-10, under 510(k) number K234106.

Who is the listed applicant for Venue Fit?

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

What is the FDA product code for Venue Fit?

The FDA product code for Venue Fit is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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