Device Classification Name |
Monitor, Uterine Contraction, External (For Use In Clinic)
|
510(k) Number |
K013477 |
Device Name |
TOCO LITE, MODEL TD-01 |
Applicant |
VENTREX, INC. |
3007 BUNSEN AVE., UNIT L & K |
VENTURA,
CA
93003
|
|
Applicant Contact |
ROBERT GUTHRIE |
Correspondent |
VENTREX, INC. |
3007 BUNSEN AVE., UNIT L & K |
VENTURA,
CA
93003
|
|
Correspondent Contact |
ROBERT GUTHRIE |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 10/19/2001 |
Decision Date | 01/17/2002 |
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
|
|
|