Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K013627 |
Device Name |
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
MEDISON AMERICA, INC. |
11075 KNOTT AVE. |
CYPRESS,
CA
90630
|
|
Applicant Contact |
A. ROBERT DEPALMA |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 11/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|