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FDA 510(k)

ZENO

K-Number: K043377 · 2005-06-01

ApplicantTyrell, Inc.
Decision Date2005-06-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZENO is the device name listed in this FDA 510(k) record. The listed applicant is Tyrell, Inc.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K043377. 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 ZENO?

ZENO is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Tyrell, Inc.. The 510(k) number is K043377.

When did ZENO receive FDA 510(k) clearance?

ZENO received FDA 510(k) clearance on 2005-06-01, under 510(k) number K043377.

Who is the listed applicant for ZENO?

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

What is the FDA product code for ZENO?

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

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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.

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