FDA 510(k)

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

K-Number: K972592 · 1997-09-15

Decision Date1997-09-15

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1997-09-15 under 510(k) number K972592. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)?

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) is a medical device that received FDA 510(k) clearance on 1997-09-15. The listed applicant is Elscint, Inc.. The 510(k) number is K972592.

When did 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) receive FDA 510(k) clearance?

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) received FDA 510(k) clearance on 1997-09-15, under 510(k) number K972592.

Who is the listed applicant for 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)?

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 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)?

The FDA product code for 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) is MOS.

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Other records listing Elscint, Inc. as applicant

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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.