Device Classification Name |
Uterine Electromyographic Monitor
|
510(k) Number |
K112390 |
Device Name |
MONICA AN24 |
Applicant |
MONICA HEALTHCARE LTD. |
BIOCITY, PENNYFOOT STREET |
NOTTINGHAM,
GB
NG1 1GF
|
|
Applicant Contact |
IAN HOW |
Correspondent |
MONICA HEALTHCARE LTD. |
BIOCITY, PENNYFOOT STREET |
NOTTINGHAM,
GB
NG1 1GF
|
|
Correspondent Contact |
IAN HOW |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 08/18/2011 |
Decision Date | 07/13/2012 |
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
|
|
|