FDA 510(k)

LOGIQ V1/ LOGIQ V2

Numéro K : K153037 · 2016-01-04

DemandeurGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Date de décision2016-01-04

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

LOGIQ V1/ LOGIQ V2 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 2016-01-04 under 510(k) number K153037. 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 V1/ LOGIQ V2?

LOGIQ V1/ LOGIQ V2 is a medical device that received FDA 510(k) clearance on 2016-01-04. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K153037.

When did LOGIQ V1/ LOGIQ V2 receive FDA 510(k) clearance?

LOGIQ V1/ LOGIQ V2 received FDA 510(k) clearance on 2016-01-04, under 510(k) number K153037.

Who is the listed applicant for LOGIQ V1/ LOGIQ V2?

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 V1/ LOGIQ V2?

The FDA product code for LOGIQ V1/ LOGIQ V2 is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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