Device Classification Name |
monitor, heart sound, fetal, ultrasonic
|
510(k) Number |
K883334 |
Device Name |
BIODOP(TM) |
Applicant |
DIAGNOSIS RELATED SYSTEMS, INC. |
7760 WEST 20TH AVE., UNIT 11 |
HIALEAH,
FL
33016
|
|
Applicant Contact |
VICTOR VALDES |
Correspondent |
DIAGNOSIS RELATED SYSTEMS, INC. |
7760 WEST 20TH AVE., UNIT 11 |
HIALEAH,
FL
33016
|
|
Correspondent Contact |
VICTOR VALDES |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 08/09/1988 |
Decision Date | 12/15/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|