Device Classification Name |
imager, ultrasonic obstetric-gynecologic
|
510(k) Number |
K942490 |
Device Name |
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND |
Applicant |
MEDICAL SOFT, INC. |
4724 LEYDEN WAY |
ELLICOTT CITY,
MD
21042 -5989
|
|
Applicant Contact |
MAYUMI M HALL |
Correspondent |
MEDICAL SOFT, INC. |
4724 LEYDEN WAY |
ELLICOTT CITY,
MD
21042 -5989
|
|
Correspondent Contact |
MAYUMI M HALL |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 05/25/1994 |
Decision Date | 02/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|