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FDA 510(k)

200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM

K-Number: K944759 · 1995-04-11

ApplicantFujinon, Inc.
Decision Date1995-04-11
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

200 SERIES GASTRO-INTESTINAL VIDEO 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 1995-04-11 under 510(k) number K944759. 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 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM?

200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Fujinon, Inc.. The 510(k) number is K944759.

When did 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM receive FDA 510(k) clearance?

200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM received FDA 510(k) clearance on 1995-04-11, under 510(k) number K944759.

Who is the listed applicant for 200 SERIES GASTRO-INTESTINAL VIDEO 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 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM?

The FDA product code for 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM 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 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: 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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