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FDA 510(k)

VISULAS TRION

K-Number: K072514 · 2007-09-21

ApplicantCarl Zeiss Meditec, AG
Decision Date2007-09-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISULAS TRION is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2007-09-21 under 510(k) number K072514. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISULAS TRION?

VISULAS TRION is a medical device that received FDA 510(k) clearance on 2007-09-21. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K072514.

When did VISULAS TRION receive FDA 510(k) clearance?

VISULAS TRION received FDA 510(k) clearance on 2007-09-21, under 510(k) number K072514.

Who is the listed applicant for VISULAS TRION?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISULAS TRION?

The FDA product code for VISULAS TRION is GEX. This falls under the Gastroenterology category.

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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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