Device Classification Name |
Imager, Ultrasonic Obstetric-Gynecologic
|
510(k) Number |
K910426 |
Device Name |
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT |
Applicant |
SHIMADZU MEDICAL SYSTEMS |
101 WEST WALNUT ST. |
GARDENIA,
CA
90248
|
|
Applicant Contact |
YUJI SHIMIZU |
Correspondent |
SHIMADZU MEDICAL SYSTEMS |
101 WEST WALNUT ST. |
GARDENIA,
CA
90248
|
|
Correspondent Contact |
YUJI SHIMIZU |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 01/30/1991 |
Decision Date | 06/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|