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FDA 510(k)

EPX-4440FN Digital Video Processor with Light Source

K-Number: K180414 · 2018-05-24

ApplicantFujifilm New Development U.S.A., Inc.
Decision Date2018-05-24
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EPX-4440FN Digital Video Processor with Light Source is a medical device manufactured by Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2018-05-24 under approval number K180414. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPX-4440FN Digital Video Processor with Light Source?

EPX-4440FN Digital Video Processor with Light Source is a medical device that received FDA 510(k) clearance on 2018-05-24. It is manufactured by Fujifilm New Development U.S.A., Inc.. The 510(k) number is K180414.

When was EPX-4440FN Digital Video Processor with Light Source approved by the FDA?

EPX-4440FN Digital Video Processor with Light Source received FDA 510(k) clearance on 2018-05-24, under approval number K180414.

What company makes EPX-4440FN Digital Video Processor with Light Source?

EPX-4440FN Digital Video Processor with Light Source is manufactured by Fujifilm New Development U.S.A., Inc..

What is the FDA product code for EPX-4440FN Digital Video Processor with Light Source?

The FDA product code for EPX-4440FN Digital Video Processor with Light Source is FET.

Related Clinical Trials

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Related PubMed Literature

PMID: 37459057 Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. JAMA internal medicine (2023)

Other Devices by Fujifilm New Development U.S.A., Inc.

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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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