Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K111227 |
Device Name |
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
ALOKA CO., LTD. |
10 FAIRFIELD BLVD. |
WALLINGFORD,
CT
06492 -7502
|
|
Applicant Contact |
YUKITOSHI KIYOMURA |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
MICHAEL S OGUNLEYE |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2011 |
Decision Date | 05/13/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|