Device Classification Name |
imager, ultrasonic obstetric-gynecologic
|
510(k) Number |
K851902 |
Device Name |
MODEL U-1000 ULTRASONIC SCANNER |
Applicant |
FUKUDA DENSHI USA, INC. |
12539 130TH LN. NE |
KIRKLAND ,
WA
98034 -
|
|
Applicant Contact |
DON ANDRESEN |
Correspondent |
FUKUDA DENSHI USA, INC. |
12539 130TH LN. NE |
KIRKLAND ,
WA
98034 -
|
|
Correspondent Contact |
DON ANDRESEN |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 04/30/1985 |
Decision Date | 09/27/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|