Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K023618 |
Device Name |
SONICAID ONE |
Applicant |
OXFORD INSTRUMENTS MEDICAL LTD. |
MANOR WAY |
OLD WOKING, SURREY,
GB
GU22 9JU
|
|
Applicant Contact |
MICHAEL EDWARDS |
Correspondent |
OXFORD INSTRUMENTS MEDICAL LTD. |
MANOR WAY |
OLD WOKING, SURREY,
GB
GU22 9JU
|
|
Correspondent Contact |
MICHAEL EDWARDS |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/29/2002 |
Decision Date | 01/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|