Device Classification Name |
Monitor, Uterine Contraction, External (For Use In Clinic)
|
510(k) Number |
K061044 |
Device Name |
FEATHERLITE AQUA TOCODYNAMOMETER |
Applicant |
VENTREX, INC. |
3007 BUNSEN AVE. |
SUITE K |
VENTURA,
CA
93003
|
|
Applicant Contact |
GEORGE AUSTRIA |
Correspondent |
VENTREX, INC. |
3007 BUNSEN AVE. |
SUITE K |
VENTURA,
CA
93003
|
|
Correspondent Contact |
GEORGE AUSTRIA |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 04/14/2006 |
Decision Date | 07/12/2006 |
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
|
|
|