Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUJIFILM EP-6000 Video Processor

K-Number: K192286 · 2020-05-01

ApplicantFujifilm Corporation
Decision Date2020-05-01
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM EP-6000 Video Processor is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2020-05-01 under approval number K192286. 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 FUJIFILM EP-6000 Video Processor?

FUJIFILM EP-6000 Video Processor is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Fujifilm Corporation. The 510(k) number is K192286.

When was FUJIFILM EP-6000 Video Processor approved by the FDA?

FUJIFILM EP-6000 Video Processor received FDA 510(k) clearance on 2020-05-01, under approval number K192286.

What company makes FUJIFILM EP-6000 Video Processor?

FUJIFILM EP-6000 Video Processor is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM EP-6000 Video Processor?

The FDA product code for FUJIFILM EP-6000 Video Processor is FET.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

View all 62 devices →

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation

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.

↑