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FDA 510(k)

ELITYS OR ELITYS-E

K-Number: K962337 · 1996-07-25

ApplicantTrophy Radiologie
Decision Date1996-07-25
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELITYS OR ELITYS-E is the device name listed in this FDA 510(k) record. The listed applicant is Trophy Radiologie. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962337. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITYS OR ELITYS-E?

ELITYS OR ELITYS-E is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Trophy Radiologie. The 510(k) number is K962337.

When did ELITYS OR ELITYS-E receive FDA 510(k) clearance?

ELITYS OR ELITYS-E received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962337.

Who is the listed applicant for ELITYS OR ELITYS-E?

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

What is the FDA product code for ELITYS OR ELITYS-E?

The FDA product code for ELITYS OR ELITYS-E is EHD.

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Other records listing Trophy Radiologie 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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Related Devices (Code: EHD)

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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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