MOBILEDIAGNOST WDR


Device Classification Name

system, x-ray, mobile

510(k) Number K111725
Device Name MOBILEDIAGNOST WDR
Applicant
SEDECAL SA
409 woodridge dr
seneca, 
SC 
29672

Applicant Contact jennifer cartledge
Correspondent
SEDECAL SA
409 woodridge dr
seneca, 
SC 
29672

Correspodent Contact jennifer cartledge
Regulation Number 892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received 06/20/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls