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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K093092
Device Name ODYSSEY WORKSTATION
Applicant
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Applicant Contact DENNIS POZZO
Correspondent
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Correspondent Contact DENNIS POZZO
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/01/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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