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FDA 510(k)

EVIS 140 SYSTEM

K-Number: K954451 · 1996-03-29

ApplicantOlympus America, Inc.
Decision Date1996-03-29
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS 140 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-03-29 under 510(k) number K954451. 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 EVIS 140 SYSTEM?

EVIS 140 SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Olympus America, Inc.. The 510(k) number is K954451.

When did EVIS 140 SYSTEM receive FDA 510(k) clearance?

EVIS 140 SYSTEM received FDA 510(k) clearance on 1996-03-29, under 510(k) number K954451.

Who is the listed applicant for EVIS 140 SYSTEM?

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

What is the FDA product code for EVIS 140 SYSTEM?

The FDA product code for EVIS 140 SYSTEM is FET.

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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