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FDA 510(k)

GATECT-RT

K-Number: K072171 · 2007-10-01

ApplicantVision RT Limited
Decision Date2007-10-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GATECT-RT is the device name listed in this FDA 510(k) record. The listed applicant is Vision RT Limited. It received FDA 510(k) clearance on 2007-10-01 under 510(k) number K072171. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GATECT-RT?

GATECT-RT is a medical device that received FDA 510(k) clearance on 2007-10-01. The listed applicant is Vision RT Limited. The 510(k) number is K072171.

When did GATECT-RT receive FDA 510(k) clearance?

GATECT-RT received FDA 510(k) clearance on 2007-10-01, under 510(k) number K072171.

Who is the listed applicant for GATECT-RT?

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

What is the FDA product code for GATECT-RT?

The FDA product code for GATECT-RT is IYE.

Related Clinical Trials

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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Other records listing Vision RT Limited 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.

K123371ALIGNRT PLUSK052682ALIGNRT

Related Devices (Code: IYE)

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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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