CS-SERIES-FP

Interventional Fluoroscopic X-ray System

OMEGA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for Cs-series-fp.

Pre-market Notification Details

Device IDK100102
510k NumberK100102
Device Name:CS-SERIES-FP
ClassificationInterventional Fluoroscopic X-ray System
Applicant OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford,  FL  32771
ContactJames Princehorn
CorrespondentJames Princehorn
OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford,  FL  32771
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeMQB
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-13
Decision Date2010-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853901007001 K100102 000
00853901007018 K100102 000

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