ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K080176
Device Name ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford, 
CT 
06492

Applicant Contact richard cehovsky
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 01/24/2008
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No