FDA 510(k)

Vivid iq

K-Nummer: K161706 · 2016-08-05

AntragstellerGe Medical Systems Ultrasound and Primary Care Diagnostics L

Entscheidungsdatum2016-08-05

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Vivid iq is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostics L. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K161706. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Vivid iq?

Vivid iq is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostics L. The 510(k) number is K161706.

When did Vivid iq receive FDA 510(k) clearance?

Vivid iq received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161706.

Who is the listed applicant for Vivid iq?

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

What is the FDA product code for Vivid iq?

The FDA product code for Vivid iq is IYN.

Zugehörige klinische Studien

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Verwandte Geräte (Code: IYN)

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