Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K901593 |
Device Name |
IMEX DOP-TONE II |
Applicant |
IMEX MEDICAL SYSTEMS, INC. |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Applicant Contact |
ED BISTRICK |
Correspondent |
IMEX MEDICAL SYSTEMS, INC. |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Correspondent Contact |
ED BISTRICK |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 04/05/1990 |
Decision Date | 07/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|