Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K002185 |
Device Name |
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
MEDISON AMERICA, INC. |
16303 PANORAMIC WAY |
SAN LEANDRO,
CA
94578 -1116
|
|
Applicant Contact |
GARY J ALLSEBROOK |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
CAROLE STAMP |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/19/2000 |
Decision Date | 08/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|