Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K001677 |
Device Name |
BABY DOPPLEX 4000 (BD4000) |
Applicant |
HUNTLEIGH DIAGNOSTICS LTD. |
35 PORTMANMOOR ROAD |
CARDIFF WALES,
GB
CF2 2HB
|
|
Applicant Contact |
B. J COLLEYPRIEST |
Correspondent |
HUNTLEIGH DIAGNOSTICS LTD. |
35 PORTMANMOOR ROAD |
CARDIFF WALES,
GB
CF2 2HB
|
|
Correspondent Contact |
B. J COLLEYPRIEST |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 06/01/2000 |
Decision Date | 08/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|