ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110207
Device Name ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford, 
CT 
06492 -7502

Applicant Contact richard cehovsky
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 01/25/2011
Decision Date 02/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No