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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 K151000
Device Name O-Arm O2 Imaging System
Applicant
MEDTRONIC INC.
300 FOSTER STREET
LITTLETON,  MA  01460
Applicant Contact RISHI SINHA
Correspondent
MEDTRONIC INC.
300 FOSTER STREET
LITTLETON,  MA  01460
Correspondent Contact RISHI SINHA
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/15/2015
Decision Date 08/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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