Device Classification Name |
Monitor, Uterine Contraction, External (For Use In Clinic)
|
510(k) Number |
K994353 |
Device Name |
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 |
Applicant |
PRECISION DYNAMICS CORP. |
13880 DEL SUR ST. |
SAN FERNANDO,
CA
91340 -3490
|
|
Applicant Contact |
KALYNA SNYLYK |
Correspondent |
PRECISION DYNAMICS CORP. |
13880 DEL SUR ST. |
SAN FERNANDO,
CA
91340 -3490
|
|
Correspondent Contact |
KALYNA SNYLYK |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 12/23/1999 |
Decision Date | 03/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|