Device Classification Name |
Monitor, Heart Rate, Fetal, Ultrasonic
|
510(k) Number |
K010920 |
Device Name |
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING |
Applicant |
MEDICAL CABLES, INC. |
1340 LOGAN AVE. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
ROBERT HILMAN |
Correspondent |
MEDICAL CABLES, INC. |
1340 LOGAN AVE. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
ROBERT HILMAN |
Regulation Number | 884.2660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/27/2001 |
Decision Date | 06/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|