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FDA 510(k)

FUJINON EDU SYSTEM

K-Number: K894763 · 1990-05-22

ApplicantFujinon, Inc.
Decision Date1990-05-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJINON EDU SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 1990-05-22 under 510(k) number K894763. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJINON EDU SYSTEM?

FUJINON EDU SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Fujinon, Inc.. The 510(k) number is K894763.

When did FUJINON EDU SYSTEM receive FDA 510(k) clearance?

FUJINON EDU SYSTEM received FDA 510(k) clearance on 1990-05-22, under 510(k) number K894763.

Who is the listed applicant for FUJINON EDU SYSTEM?

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 EDU SYSTEM?

The FDA product code for FUJINON EDU SYSTEM is ITX.

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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 COLONOSCOPESK102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORK111243FUJINON ULTRASONIC PROCESSORK091773FUJINON STERILE OVERTUBESK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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