FDA 510(k)

ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D

K-Number: K002749 · 2000-12-04

Decision Date2000-12-04

Product CodeFDF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002749. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D?

ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is The Olympus Optical Co.. The 510(k) number is K002749.

When did ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D receive FDA 510(k) clearance?

ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002749.

Who is the listed applicant for ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D?

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

What is the FDA product code for ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D?

The FDA product code for ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D is FDF.

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Other records listing The Olympus Optical Co. as applicant

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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.