Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K150398 |
Device Name |
EUM 100Pro |
Applicant |
OB TOOLS, LTD. |
MIFALEY HAEMEK INDUSTRIAL ZONE |
P.O. BOX 667 |
MIGDAL HA-EMEK,
IL
2310502
|
|
Applicant Contact |
GAL BEN DAVID |
Correspondent |
PROMEDIC, INC. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134 -2958
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 08/06/2015 |
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
|
|
|