SATURN 9000-550


Device Classification Name

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

510(k) Number K072984
Device Name SATURN 9000-550
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 10/23/2007
Decision Date 11/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No