Device Classification Name |
Monitor, Uterine Contraction, External (For Use In Clinic)
|
510(k) Number |
K140163 |
Device Name |
KOALA TOCO |
Applicant |
CLINICAL INNOVATIONS, LLC |
62 FOREST STREET, STE 300 |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
JOANNE BRONIKOWSKI |
Correspondent |
CLINICAL INNOVATIONS, LLC |
62 FOREST STREET, STE 300 |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
JOANNE BRONIKOWSKI |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 01/22/2014 |
Decision Date | 05/29/2014 |
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
|
|
|