Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K002150 |
Device Name |
SONICAID FM820, SONICAID FM830 |
Applicant |
OXFORD INSTRUMENTS |
MANOR WAY |
OLD WOKING, SURREY,
GB
GU22 9JU
|
|
Applicant Contact |
STEVE VALE |
Correspondent |
OXFORD INSTRUMENTS |
MANOR WAY |
OLD WOKING, SURREY,
GB
GU22 9JU
|
|
Correspondent Contact |
STEVE VALE |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 07/17/2000 |
Decision Date | 03/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|