FDA 510(k)

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3

Numéro K : K161224 · 2016-08-05

DemandeurGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Date de décision2016-08-05

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 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 2016-08-05 under 510(k) number K161224. 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 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3?

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161224.

When did LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 receive FDA 510(k) clearance?

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161224.

Who is the listed applicant for LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3?

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 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3?

The FDA product code for LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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