Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K040819 |
Device Name |
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 |
Applicant |
AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. |
HANOVER,
MD
21076
|
|
Applicant Contact |
GREGORY FALK |
Correspondent |
AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. |
HANOVER,
MD
21076
|
|
Correspondent Contact |
GREGORY FALK |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 03/30/2004 |
Decision Date | 08/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|