OLYMPUS BF TYPE UC160-OL8

Endoscopic Ultrasound System, Gastroenterology-urology

OLYMPUS CORPORATION

The following data is part of a premarket notification filed by Olympus Corporation with the FDA for Olympus Bf Type Uc160-ol8.

Pre-market Notification Details

Device IDK042140
510k NumberK042140
Device Name:OLYMPUS BF TYPE UC160-OL8
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant OLYMPUS CORPORATION TWO CORPORATE CENTER DRIVE Melville,  NY  11747 -3157
ContactTina Steffanie-oak
CorrespondentDerwyn Reuber
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeODG  
Subsequent Product CodeEOQ
Subsequent Product CodeFDS
Subsequent Product CodeITX
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-08-09
Decision Date2004-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170360459 K042140 000
04953170355981 K042140 000
04953170175626 K042140 000
14953170175616 K042140 000

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