Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K871082 |
Device Name |
FETAL CARE MONITOR ANTEPARTUM 1500 |
Applicant |
PIE DATA MEDICAL BV |
PHILIPSWEG 1 |
MAASTRICHT 6227 AJ,
NL
|
|
Applicant Contact |
RIKERS |
Correspondent |
PIE DATA MEDICAL BV |
PHILIPSWEG 1 |
MAASTRICHT 6227 AJ,
NL
|
|
Correspondent Contact |
RIKERS |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 03/18/1987 |
Decision Date | 08/04/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|