FDA 510(k)

GE DISCOVERY ST

K-Number: K041543 · 2004-06-22

Decision Date2004-06-22

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE DISCOVERY ST is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K041543. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DISCOVERY ST?

GE DISCOVERY ST is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is GE Healthcare. The 510(k) number is K041543.

When did GE DISCOVERY ST receive FDA 510(k) clearance?

GE DISCOVERY ST received FDA 510(k) clearance on 2004-06-22, under 510(k) number K041543.

Who is the listed applicant for GE DISCOVERY ST?

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

What is the FDA product code for GE DISCOVERY ST?

The FDA product code for GE DISCOVERY ST is KPS.

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Official Source

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