Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K760728 |
Device Name |
CONTINUOUS WAVE DOPPLER ULTRASOUND |
Applicant |
MEDSONICS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDSONICS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 09/27/1976 |
Decision Date | 10/06/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|