FDA 510(k)

SENOGRAPHIC STEREO

K-Number: K040125 · 2004-04-19

Decision Date2004-04-19

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SENOGRAPHIC STEREO is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-04-19 under 510(k) number K040125. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENOGRAPHIC STEREO?

SENOGRAPHIC STEREO is a medical device that received FDA 510(k) clearance on 2004-04-19. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K040125.

When did SENOGRAPHIC STEREO receive FDA 510(k) clearance?

SENOGRAPHIC STEREO received FDA 510(k) clearance on 2004-04-19, under 510(k) number K040125.

Who is the listed applicant for SENOGRAPHIC STEREO?

The FDA 510(k) record lists Ge Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENOGRAPHIC STEREO?

The FDA product code for SENOGRAPHIC STEREO is IZH.

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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.