Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K132650 |
Device Name |
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM |
Applicant |
HUNTLEIGH HEALTHCARE LIMITED |
35 PORTMANMOOR ROAD |
CARDIFF, WALES,
GB
CF24 5HN
|
|
Applicant Contact |
LAURA GARCIA DEACON |
Correspondent |
HUNTLEIGH HEALTHCARE LIMITED |
35 PORTMANMOOR ROAD |
CARDIFF, WALES,
GB
CF24 5HN
|
|
Correspondent Contact |
LAURA GARCIA DEACON |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 08/26/2013 |
Decision Date | 02/07/2014 |
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
|
|
|