ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K080800
Device Name ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
MEDISON CO., LTD.
1003, daechi-dong
gangnam-gu
seoul, 

KR

135-280

Applicant Contact shim kyung-am
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 03/21/2008
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No