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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 K173664
Device Name Medtronic O-arm O2 Imaging System
Applicant
Medtronic, Inc.
300 Foster St.
Littleton,  MA  01460
Applicant Contact Dean Honkonen
Correspondent
Medtronic, Inc.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact Dean Honkonen
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received11/29/2017
Decision Date 12/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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