Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K050234 |
Device Name |
REMOTE CARE |
Applicant |
E.CARE SOLUTIONS, INC. |
6740 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE G BUNDY |
Correspondent |
E.CARE SOLUTIONS, INC. |
6740 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE G BUNDY |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 02/01/2005 |
Decision Date | 08/25/2005 |
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
|
|
|