Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K940898 |
Device Name |
MODEL IM77 INTRAPARTUM FETAL MONITOR |
Applicant |
ADVANCED MEDICAL SYSTEMS, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Applicant Contact |
ANTHONY CALDERONI |
Correspondent |
ADVANCED MEDICAL SYSTEMS, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Correspondent Contact |
ANTHONY CALDERONI |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 02/24/1994 |
Decision Date | 03/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|