Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K994008 |
Device Name |
BIOSYS FETAL MONITOR, MODEL IFM-500 |
Applicant |
BIOSYS CO. LTD. |
16303 PANORAMIC WAY |
SAN LEANDRO,
CA
94578
|
|
Applicant Contact |
GARY J ALLSEBROOK |
Correspondent |
BIOSYS CO. LTD. |
16303 PANORAMIC WAY |
SAN LEANDRO,
CA
94578
|
|
Correspondent Contact |
GARY J ALLSEBROOK |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 11/24/1999 |
Decision Date | 09/29/2000 |
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
|
|
|