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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K200074
Device Name O-arm O2 Imaging System
Medtronic Inc.
300 Foster St.
Littleton,  MA  01460
Applicant Contact Dean Honkonen
Medtronic Inc.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact Dean Honkonen
Regulation Number892.1650
Classification Product Code
Subsequent Product Codes
Date Received01/14/2020
Decision Date 04/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No