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FDA 510(k)

OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER

K-Number: K070071 · 2007-01-25

ApplicantOmniguide, Inc.
Decision Date2007-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K070071. 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 OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER?

OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Omniguide, Inc.. The 510(k) number is K070071.

When did OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER receive FDA 510(k) clearance?

OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER received FDA 510(k) clearance on 2007-01-25, under 510(k) number K070071.

Who is the listed applicant for OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER?

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

What is the FDA product code for OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER?

The FDA product code for OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER 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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