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FDA 510(k)

RADIFORCE LARGE MONITOR SYSTEM

K-Number: K112645 · 2011-09-22

ApplicantEizo GmbH
Decision Date2011-09-22
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIFORCE LARGE MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eizo GmbH. It received FDA 510(k) clearance on 2011-09-22 under 510(k) number K112645. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIFORCE LARGE MONITOR SYSTEM?

RADIFORCE LARGE MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Eizo GmbH. The 510(k) number is K112645.

When did RADIFORCE LARGE MONITOR SYSTEM receive FDA 510(k) clearance?

RADIFORCE LARGE MONITOR SYSTEM received FDA 510(k) clearance on 2011-09-22, under 510(k) number K112645.

Who is the listed applicant for RADIFORCE LARGE MONITOR SYSTEM?

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

What is the FDA product code for RADIFORCE LARGE MONITOR SYSTEM?

The FDA product code for RADIFORCE LARGE MONITOR SYSTEM is DXJ.

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Other records listing Eizo GmbH 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.

K10372410 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)K0813575MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)

Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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