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FDA 510(k)

GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102

K-Number: K965044 · 1997-06-16

ApplicantElscint, Inc.
Decision Date1997-06-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K965044. 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 MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102?

GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Elscint, Inc.. The 510(k) number is K965044.

When did GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 receive FDA 510(k) clearance?

GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 received FDA 510(k) clearance on 1997-06-16, under 510(k) number K965044.

Who is the listed applicant for GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102?

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 MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102?

The FDA product code for GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 is LNH.

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Other records listing Elscint, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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