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FDA 510(k)

REVOLIX AND REVOLIX JR

K-Number: K051167 · 2005-06-01

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

Device Summary

REVOLIX AND REVOLIX JR is the device name listed in this FDA 510(k) record. The listed applicant is Allmed Systems, Inc.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K051167. 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 REVOLIX AND REVOLIX JR?

REVOLIX AND REVOLIX JR is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Allmed Systems, Inc.. The 510(k) number is K051167.

When did REVOLIX AND REVOLIX JR receive FDA 510(k) clearance?

REVOLIX AND REVOLIX JR received FDA 510(k) clearance on 2005-06-01, under 510(k) number K051167.

Who is the listed applicant for REVOLIX AND REVOLIX JR?

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

What is the FDA product code for REVOLIX AND REVOLIX JR?

The FDA product code for REVOLIX AND REVOLIX JR is GEX. This falls under the Gastroenterology category.

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Other records listing Allmed Systems, Inc. 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.

K110941REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200K070924FLEXGUARDK070466REVOLIX DUO LASER SYSTEMK070476REVOLIX 120K033437SPHINX LASER SYSTEMSK033423REVOLIX LASER SYSTEMS

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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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