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FDA 510(k)

FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR

K-Number: K102466 · 2011-05-25

ApplicantFujinon, Inc.
Decision Date2011-05-25
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2011-05-25 under 510(k) number K102466. 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 FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR?

FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is Fujinon, Inc.. The 510(k) number is K102466.

When did FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR receive FDA 510(k) clearance?

FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR received FDA 510(k) clearance on 2011-05-25, under 510(k) number K102466.

Who is the listed applicant for FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR?

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

What is the FDA product code for FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR?

The FDA product code for FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR is FET.

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Other records listing Fujinon, 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.

K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2K112391FUJINON COLONOSCOPESK111243FUJINON ULTRASONIC PROCESSORK091773FUJINON STERILE OVERTUBESK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15K063316FUJINON MODEL EG-530N TRANS NASAL INSERTION

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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