Medtronic 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 Medtronic O-arm O2 Imaging System.

Pre-market Notification Details

Device IDK173664
510k NumberK173664
Device Name:Medtronic 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-29
Decision Date2017-12-29
Summary:summary

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