OLYMPUS MH-246R BALLOON SHEATH

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 Mh-246r Balloon Sheath.

Pre-market Notification Details

Device IDK961048
510k NumberK961048
Device Name:OLYMPUS MH-246R BALLOON SHEATH
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactBarry E Sands
CorrespondentBarry E Sands
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 Received1996-03-15
Decision Date1996-09-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170365130 K961048 000
14953170365123 K961048 000
14953170365116 K961048 000
14953170061872 K961048 000
14953170059077 K961048 000
14953170058995 K961048 000
14953170463515 K961048 000
14953170463508 K961048 000

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