ODYSSEY WORKSTATION


Device Classification Name

system, catheter control, steerable

510(k) Number K072371
Device Name ODYSSEY WORKSTATION
Applicant
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis, 
MO 
63108

Applicant Contact dennis pozzo
Correspondent
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis, 
MO 
63108

Correspodent Contact dennis pozzo
Regulation Number 870.1290
Classification Product Code
DXX  
Date Received 08/23/2007
Decision Date 11/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No