Device Classification Name |
monitor, uterine contraction, external (for use in clinic)
|
510(k) Number |
K874631 |
Device Name |
HEALTHPHONE TOCO MODEL |
Applicant |
CARELINK |
22936 MILL CREEK DR. |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
RICHARD C LIGGITT |
Correspondent |
CARELINK |
22936 MILL CREEK DR. |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
RICHARD C LIGGITT |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 11/10/1987 |
Decision Date | 03/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|