ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT

System, Imaging, Gastrointestinal, Wireless, Capsule

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endocapsule Software 10; Endocapsule Software 10 Light.

Pre-market Notification Details

Device IDK142680
510k NumberK142680
Device Name:ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
ClassificationSystem, Imaging, Gastrointestinal, Wireless, Capsule
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi,  JP 192-8507
ContactDaphney Germain-kolawole
CorrespondentDaphney Germain-kolawole
OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeNEZ  
CFR Regulation Number876.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-19
Decision Date2015-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170373845 K142680 000
14953170373807 K142680 000
14953170373760 K142680 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.