Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K871385 |
Device Name |
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION |
Applicant |
FUKUDA DENSHI USA, INC. |
12539 130TH LN. NE |
KIRKLAND ,
WA
98034 -
|
|
Applicant Contact |
DONALD ANDRESEN |
Correspondent |
FUKUDA DENSHI USA, INC. |
12539 130TH LN. NE |
KIRKLAND ,
WA
98034 -
|
|
Correspondent Contact |
DONALD ANDRESEN |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/07/1987 |
Decision Date | 05/26/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|