VIDEO SYSTEM CENTER

Led Light Source

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Video System Center.

Pre-market Notification Details

Device IDK122831
510k NumberK122831
Device Name:VIDEO SYSTEM CENTER
ClassificationLed Light Source
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
Product CodeNTN  
Subsequent Product CodeFET
Subsequent Product CodeNWB
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-17
Decision Date2012-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170338502 K122831 000
04953170338496 K122831 000

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