Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K000030 |
Device Name |
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
MEDISON AMERICA, INC. |
6616 OWENS DR. |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
GARY J ALLESBROOK |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
CAROLE STAMP |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 01/05/2000 |
Decision Date | 01/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|