Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K963711 |
Device Name |
BABY DOPPLEX (3000) |
Applicant |
HUNTLEIGH HEALTHCARE, INC. |
227 RT. 33 EAST |
MANALAPAN,
NJ
07726
|
|
Applicant Contact |
AUDREY WITKO |
Correspondent |
HUNTLEIGH HEALTHCARE, INC. |
227 RT. 33 EAST |
MANALAPAN,
NJ
07726
|
|
Correspondent Contact |
AUDREY WITKO |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 09/16/1996 |
Decision Date | 09/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|