Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K010552 |
Device Name |
CG-900P FETAL/MATERNAL MONITOR |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
REHOVOT,
IL
76100
|
|
Applicant Contact |
LEONID TRACHTENBERG |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
LEONID TRACHTENBERG |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 02/26/2001 |
Decision Date | 05/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|