Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K122341 |
Device Name |
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 |
Applicant |
HITACHI ALOKA MEDICAL, LTD. |
10 FAIRFIELD BLVD. |
WALLINGFORD CT,
CT
06492 -7502
|
|
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
1279 QUARRY LANE, SUITE A |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
MICHAEL S OGUNLEYE |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/02/2012 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|