SATURN 9000-810


Device Classification Name

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

510(k) Number K080589
Device Name SATURN 9000-810
Applicant
NEW MEDICAL CO., LTD.
4f, no.42, singzhong rd.
neihu district
taipei, 

TW

114

Applicant Contact young-hoon shin
Correspondent
NEW MEDICAL CO., LTD.
4f, no.42, singzhong rd.
neihu district
taipei, 

TW

114

Correspodent Contact young-hoon shin
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 03/03/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No