Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K991858 |
Device Name |
SSA-390A/POWER VISION 8000 |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Applicant Contact |
PAUL BIGGINS |
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 | 06/01/1999 |
Decision Date | 06/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|