Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K010894 |
Device Name |
BABY DOPPLEX 3002 (BD3002) |
Applicant |
HUNTLEIGH HEALTHCARE, INC. |
35 PORTMANMOOR ROAD |
CARDIFF,
GB
CF24 5HN
|
|
Applicant Contact |
B.J. COLLEYPRIEST |
Correspondent |
HUNTLEIGH HEALTHCARE, INC. |
35 PORTMANMOOR ROAD |
CARDIFF,
GB
CF24 5HN
|
|
Correspondent Contact |
B.J. COLLEYPRIEST |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 03/26/2001 |
Decision Date | 04/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|