Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K912639 |
Device Name |
SONICAID TEAM |
Applicant |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Applicant Contact |
CHARLES HOLZ |
Correspondent |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Correspondent Contact |
CHARLES HOLZ |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 06/14/1991 |
Decision Date | 12/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|