OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE

Gastroscope And Accessories, Flexible/rigid

OLYMPUS OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Xgif-n200h Gastrointestinal Videoscope.

Pre-market Notification Details

Device IDK001766
510k NumberK001766
Device Name:OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-taylor
CorrespondentLaura Storms-taylor
OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-12
Decision Date2000-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170340376 K001766 000
04953170286445 K001766 000
04953170156113 K001766 000
04953170156106 K001766 000
04953170154096 K001766 000

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