SATURN 8000-GS


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K110210
Device Name SATURN 8000-GS
Applicant
NEW MEDICAL CO., LTD.
1460 atterbury dr.
walnut, 
CA 
91789

Applicant Contact jun-hsiung lin
Correspondent
NEW MEDICAL CO., LTD.
1460 atterbury dr.
walnut, 
CA 
91789

Correspodent Contact jun-hsiung lin
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 01/25/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No