STEREOS WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K080529
Device Name STEREOS WORKSTATION
Applicant
BIOSPACE MED
555 thirteenth st. nw
washington, 
DC 
20004

Applicant Contact john j smith
Correspondent
BIOSPACE MED
555 thirteenth st. nw
washington, 
DC 
20004

Correspodent Contact john j smith
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/26/2008
Decision Date 08/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No