Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K140639 |
Device Name |
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
HITACHI ALOKA MEDICAL, LTD. |
10 FAIRFIELD BLVD. |
WALLINGFORD CT,
CT
06492 -7502
|
|
Applicant Contact |
ANGELA VANARSDALE |
Correspondent |
HITACHI ALOKA MEDICAL, LTD. |
10 FAIRFIELD BLVD. |
WALLINGFORD CT,
CT
06492 -7502
|
|
Correspondent Contact |
ANGELA VANARSDALE |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/12/2014 |
Decision Date | 04/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|