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FDA 510(k)

OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS

K-Number: K853585 · 1986-01-21

ApplicantOlympus Corp.
Decision Date1986-01-21
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K853585. 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 OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS?

OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Olympus Corp.. The 510(k) number is K853585.

When did OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS receive FDA 510(k) clearance?

OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS received FDA 510(k) clearance on 1986-01-21, under 510(k) number K853585.

Who is the listed applicant for OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS?

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

What is the FDA product code for OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS?

The FDA product code for OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS is FET.

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Other records listing Olympus Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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