Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K072698 |
Device Name |
CONFIDANT 2.5 |
Applicant |
CONFIDANT INC. |
2530 MERIDIAN PARKWAY |
SUITE 300 |
DURHAM,
NC
27713
|
|
Applicant Contact |
DANIEL R PLONSKI |
Correspondent |
CONFIDANT INC. |
2530 MERIDIAN PARKWAY |
SUITE 300 |
DURHAM,
NC
27713
|
|
Correspondent Contact |
DANIEL R PLONSKI |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 09/24/2007 |
Decision Date | 11/16/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|