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FDA 510(k)

3D PROCESSING OPTIONS FOR GYREX

K-Number: K915579 · 1992-02-18

ApplicantElscint, Inc.
Decision Date1992-02-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D PROCESSING OPTIONS FOR GYREX is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K915579. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D PROCESSING OPTIONS FOR GYREX?

3D PROCESSING OPTIONS FOR GYREX is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Elscint, Inc.. The 510(k) number is K915579.

When did 3D PROCESSING OPTIONS FOR GYREX receive FDA 510(k) clearance?

3D PROCESSING OPTIONS FOR GYREX received FDA 510(k) clearance on 1992-02-18, under 510(k) number K915579.

Who is the listed applicant for 3D PROCESSING OPTIONS FOR GYREX?

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

What is the FDA product code for 3D PROCESSING OPTIONS FOR GYREX?

The FDA product code for 3D PROCESSING OPTIONS FOR GYREX is LNH.

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Other records listing Elscint, Inc. as applicant

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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.

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