Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K142883 |
Device Name |
MindChild Meridian M100 Fetal Heart Rate Monitor |
Applicant |
Mindchild Medical |
1600 Osgood Street #2-17 |
North Andover,
MA
01845
|
|
Applicant Contact |
Jim Robertson |
Correspondent |
NorthStar Biomedical Associates |
93 Benefit Street |
Providence,
RI
02904
|
|
Correspondent Contact |
Leo Basta |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 10/02/2014 |
Decision Date | 04/17/2015 |
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
|
|
|