MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA


Device Classification Name

system, x-ray, stationary

510(k) Number K080582
Device Name MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
Applicant
MEDICATECH USA
po box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
MEDICATECH USA
po box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received 03/03/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No