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FDA 510(k)

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200

K-Number: K110941 · 2013-02-19

ApplicantAllmed Systems, Inc.
Decision Date2013-02-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 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 2013-02-19 under 510(k) number K110941. 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 JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200?

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 is a medical device that received FDA 510(k) clearance on 2013-02-19. The listed applicant is Allmed Systems, Inc.. The 510(k) number is K110941.

When did REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 receive FDA 510(k) clearance?

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 received FDA 510(k) clearance on 2013-02-19, under 510(k) number K110941.

Who is the listed applicant for REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200?

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 JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200?

The FDA product code for REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 is GEX. This falls under the Gastroenterology category.

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Other records listing Allmed Systems, Inc. as applicant

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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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