Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K013281 |
Device Name |
VERSALAB APM |
Applicant |
NICOLET BIOMEDICAL |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Applicant Contact |
DAVID W WAGNER |
Correspondent |
NICOLET BIOMEDICAL |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Correspondent Contact |
DAVID W WAGNER |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 10/02/2001 |
Decision Date | 04/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|