Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K903992 |
Device Name |
CYGNET CENTRAL |
Applicant |
CYGNET CO., INC. |
844 JURY CT. |
SAN JOSE,
CA
95112
|
|
Applicant Contact |
RUDAIN ARAFEH |
Correspondent |
CYGNET CO., INC. |
844 JURY CT. |
SAN JOSE,
CA
95112
|
|
Correspondent Contact |
RUDAIN ARAFEH |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 08/29/1990 |
Decision Date | 12/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|