FDA 510(k)

GE VIVID 7, MODEL FC0003XX

K-Number: K031663 · 2003-06-09

Decision Date2003-06-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE VIVID 7, MODEL FC0003XX is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2003-06-09 under 510(k) number K031663. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE VIVID 7, MODEL FC0003XX?

GE VIVID 7, MODEL FC0003XX is a medical device that received FDA 510(k) clearance on 2003-06-09. The listed applicant is General Electric Co.. The 510(k) number is K031663.

When did GE VIVID 7, MODEL FC0003XX receive FDA 510(k) clearance?

GE VIVID 7, MODEL FC0003XX received FDA 510(k) clearance on 2003-06-09, under 510(k) number K031663.

Who is the listed applicant for GE VIVID 7, MODEL FC0003XX?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE VIVID 7, MODEL FC0003XX?

The FDA product code for GE VIVID 7, MODEL FC0003XX is IYN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.