O-arm O2 Imaging System

Interventional Fluoroscopic X-ray System

Medtronic Inc.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for O-arm O2 Imaging System.

Pre-market Notification Details

Device IDK200074
510k NumberK200074
Device Name:O-arm O2 Imaging System
ClassificationInterventional Fluoroscopic X-ray System
Applicant Medtronic Inc. 300 Foster St. Littleton,  MA  01460
ContactDean Honkonen
CorrespondentDean Honkonen
Medtronic Inc. 300 Foster St. Littleton,  MA  01460
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-14
Decision Date2020-04-24

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.