RFVISION, MODEL 9.9D


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K080847
Device Name RFVISION, MODEL 9.9D
Applicant
ALMANA MEDICAL IMAGING
po box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm, p.e
Correspondent
ALMANA MEDICAL IMAGING
po box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm, p.e
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 03/26/2008
Decision Date 08/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No