GF-UE160-AL5 ULTRASOUND ENDOSCOPE

Colonoscope And Accessories, Flexible/rigid

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Gf-ue160-al5 Ultrasound Endoscope.

Pre-market Notification Details

Device IDK051541
510k NumberK051541
Device Name:GF-UE160-AL5 ULTRASOUND ENDOSCOPE
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentNeil E Devine
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-06-10
Decision Date2005-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170360428 K051541 000
04953170062865 K051541 000
04953170062971 K051541 000
04953170203107 K051541 000
04953170310546 K051541 000
04953170355349 K051541 000
04953170355974 K051541 000
04953170356148 K051541 000
04953170356261 K051541 000
14953170058780 K051541 000

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