ENDOSCOPIC ULTRASOUND CENTER EU-Y0006

System, Imaging, Pulsed Doppler, Ultrasonic

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscopic Ultrasound Center Eu-y0006.

Pre-market Notification Details

Device IDK121564
510k NumberK121564
Device Name:ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeODG
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-29
Decision Date2012-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170343490 K121564 000
04953170343384 K121564 000
04953170418013 K121564 000

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