ODYSSEY WORKSTATION

Computer, Diagnostic, Programmable

STEREOTAXIS, INC.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Odyssey Workstation.

Pre-market Notification Details

Device IDK093092
510k NumberK093092
Device Name:ODYSSEY WORKSTATION
ClassificationComputer, Diagnostic, Programmable
Applicant STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis,  MO  63108
ContactDennis Pozzo
CorrespondentDennis Pozzo
STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis,  MO  63108
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-01
Decision Date2010-01-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.