OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

Endoscopic Ultrasound System, Gastroenterology-urology

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Eu-m60 Eus Exera Endoscopic Ultrasound Ctr, Eus Exera Ultrasonic Gastrovideoscope Olympus Gf Type Um 160,.

Pre-market Notification Details

Device IDK011886
510k NumberK011886
Device Name:OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeODG  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-15
Decision Date2001-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170368462 K011886 000
04953170136559 K011886 000
04953170136566 K011886 000
04953170136573 K011886 000
04953170136603 K011886 000
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04953170181733 K011886 000
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04953170355806 K011886 000
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04953170355851 K011886 000
04953170356155 K011886 000
04953170368431 K011886 000
04953170368448 K011886 000
04953170228971 K011886 000

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