Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K032329 |
Device Name |
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
MEDISON AMERICA, INC. |
11075 KNOTT AVE. |
CYPRESS,
CA
90630
|
|
Applicant Contact |
A. ROBERT DEPALMA |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/2003 |
Decision Date | 08/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|