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FDA 510(k)

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP

K-Number: K980306 · 1998-04-02

ApplicantElscint, Inc.
Decision Date1998-04-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980306. 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 GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP?

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Elscint, Inc.. The 510(k) number is K980306.

When did GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP receive FDA 510(k) clearance?

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980306.

Who is the listed applicant for GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP?

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 GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP?

The FDA product code for GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP is LNH.

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Official Source

View on FDA Database →

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